Cancer that begins in glandular (secretory) cells. Glandular cells are found in tissue that lines certain internal organs and makes and releases substances in the body, such as mucus, digestive juices, or other fluids. Most cancers of the breast, pancreas, lung, prostate, and colon are adenocarcinomas.
A tumor that is not cancer. It starts in gland-like cells of the epithelial tissue (thin layer of tissue that covers organs, glands, and other structures within the body).
A type of cancer that contains two types of cells: squamous cells (thin, flat cells that line certain organs) and gland-like cells.
Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
Adoptive Cellular Therapy
A treatment used to help the immune system fight diseases, such as cancer and infections with certain viruses. T cells are collected from a patient and grown in the laboratory. This increases the number of T cells that are able to kill cancer cells or fight infections. These T cells are given back to the patient to help the immune system fight disease. Also called cellular adoptive immunotherapy.
A legal document that states the treatment or care a person wishes to receive or not receive if he or she becomes unable to make medical decisions (for example, due to being unconscious or in a coma). Some types of advance directives are living wills and do-not-resuscitate (DNR) orders.
An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. Also called adverse effect.
A drug or substance that binds to a receptor inside a cell or on its surface and causes the same action as the substance that normally binds to the receptor.
A measure of the number of neutrophils in the blood. Neutrophils are a type of white blood cell. They help the body fight infection. An ANC may be used to check for infection, inflammation, leukemia, and other conditions. The lower a person's ANC is, the higher the risk is of getting an infection. Having an ANC of less than 500 means there is a high risk of getting an infection. Cancer treatment, such as chemotherapy, may reduce the ANC. Also called absolute neutrophil count.
A condition in which the number of red blood cells is below normal.
Blood vessel formation. Tumor angiogenesis is the growth of new blood vessels that tumors need to grow. This process is caused by the release of chemicals by the tumor and by host cells near the tumor.
In medicine, a substance that stops the action or effect of another substance. For example, a drug that blocks the stimulating effect of estrogen on a tumor cell is called an estrogen receptor antagonist.
A substance made up of a monoclonal antibody chemically linked to a drug. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Some antibody-drug conjugates are used to treat cancer. Also called ADC.
Any substance that causes the body to make an immune response against that substance. Antigens include toxins, chemicals, bacteria, viruses, or other substances that come from outside the body. Body tissues and cells, including cancer cells, also have antigens on them that can cause an immune response. These antigens can also be used as markers in laboratory tests to identify those tissues or cells.
A type of cell death in which a series of molecular steps in a cell lead to its death. This is one method the body uses to get rid of unneeded or abnormal cells. The process of apoptosis may be blocked in cancer cells. Also called programmed cell death.
American Society of Gene and Cell Therapy; The American Society of Gene & Cell Therapy (ASGCT) is a non-profit medical and professional organization that represents researchers and scientists devoted to the discovery of new genetic and cellular therapies.
Taken from an individual's own tissues, cells, or DNA.
A small, round cell found in the lower part (or base) of the epidermis, the outer layer of the skin.
An initial measurement that is taken at an early time point to represent a beginning condition, and is used for comparison over time to look for changes. For example, the size of a tumor will be measured before treatment (baseline) and then afterwards to see if the treatment had an effect.
A type of immune cell that has granules (small particles) with enzymes that are released during allergic reactions and asthma. A basophil is a type of white blood cell and a type of granulocyte.
A type of white blood cell that makes antibodies. B cells are part of the immune system and develop from stem cells in the bone marrow. Also called B lymphocyte.
Not cancerous. Benign tumors may grow larger but do not spread to other parts of the body. Also called nonmalignant.
The science of using computers, databases, and math to organize and analyze large amounts of biological, medical, and health information. Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials.
A medicinal preparation made from living organisms and their products, such as a serum or vaccine. RNA interference is a natural process in which expression of a targeted gene is blocked with high specificity and selectivity. The bifunctional RNAi technology clinically tested at Mary Crowley is designed to take advantage of the natural gene silencing machinery within the cell.
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
The removal of cells or tissues for examination by a pathologist. The pathologist may study the tissue under a microscope or perform other tests on the cells or tissue. There are many different types of biopsy procedures. The most common types include: (1) incisional biopsy, in which only a sample of tissue is removed; (2) excisional biopsy, in which an entire lump or suspicious area is removed; and (3) needle biopsy, in which a sample of tissue or fluid is removed with a needle. When a wide needle is used, the procedure is called a core biopsy. When a thin needle is used, the procedure is called a fine-needle aspiration biopsy.
A facility that collects, catalogs, and stores samples of biological material, such as urine, blood, tissue, cells, DNA, RNA, and protein, from humans, animals, or plants for laboratory research. If the samples are from people, medical information may also be stored along with a written consent to use the samples in laboratory studies.
Used by scientists to study contagious materials safely and effectively. These state-of-the-art labs are designed not only to protect researchers from contamination, but also to prevent microorganisms from entering the environment.
A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. The opposite of a blinded study is an open label study.
Body Mass Index
A measure that relates body weight to height. BMI is sometimes used to measure total body fat and whether a person is a healthy weight. Excess body fat is linked to an increased risk of some diseases including heart disease and some cancers. Also called BMI.
Bone Marrow Samples
An area of bone (usually the pelvic bone) is numbed and a small amount of bone and bone marrow are drawn out with a needle.
A radioactive chemical is injected into the vein; this is taken up by the bones. It is then possible to see abnormal areas in the bones.
After receiving medicine to cause sleepiness, a tube is passed through the throat into the lungs to examine the air passages.
A disease caused by an uncontrolled division of abnormal cells in a part of the body.
A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin).
Blood samples for routine tests.
CEA Blood Tests
A blood sample used to measure a protein that is present in the blood in some types of cancer.
In biology, the smallest unit that can live on its own and that makes up all living organisms and the tissues of the body. A cell has three main parts: the cell membrane, the nucleus, and the cytoplasm. The cell membrane surrounds the cell and controls the substances that go into and out of the cell. The nucleus is a structure inside the cell that contains the nucleolus and most of the cell’s DNA. It is also where most RNA is made. The cytoplasm is the fluid inside the cell. It contains other tiny cell parts that have specific functions, including the Golgi complex, the mitochondria, and the endoplasmic reticulum. The cytoplasm is where most chemical reactions take place and most proteins get made. The human body has more than 30 trillion cells.
The process a cell goes through each time it divides. The cell cycle consists of a series of steps during which the chromosomes and other cell material double to make two copies. The cell then divides into two daughter cells, each receiving one copy of the doubled material. The cell cycle is complete when each daughter cell is surrounded by its own outer membrane. Also called mitotic cycle.
The transplantation of human or animal cells to replace or repair damaged tissue.
Certified IRB Professional
Certification awarded to persons who satisfy the educational and employment requirements and pass an examination conducted by the Applied Research Ethics National Association (ARENA), the membership division of Public Responsibility in Medicine and Research (PRIM&R).
A drug that makes tumor cells more sensitive to the effects of chemotherapy.
Treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemotherapy may be given by mouth, injection, or infusion, or on the skin, depending on the type and stage of the cancer being treated. It may be given alone or with other treatments, such as surgery, radiation therapy, and/or biologic therapy.
Circulating Tumor DNA
Small pieces of DNA released by dying tumor cells into the bloodstream. Can be used to screen for somatic mutations as a way to detect and follow the progression of a patient’s tumor.
Is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations must be adhered to. The foundations for these regulations are defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and regulatory authorities, which set the guidelines for good clinical practice (GCP) at clinical sites.
A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device.
Comprehensive Metabolic Panel (CMP) is a blood test that measures sugar (glucose) levels, electrolyte and fluid balance, kidney, and liver function.
A group of individuals who share a common trait, such as birth year. In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time.
Therapy that combines more than one method of treatment. Also called multimodality therapy and multimodality treatment.
Treatments that are used along with standard treatments but are not considered standard. Standard treatments are based on the results of scientific research and are currently accepted and widely used. Less research has been done for most types of complementary medicine. Complementary medicine includes acupuncture, dietary supplements, massage therapy, hypnosis, and meditation. For example, acupuncture may be used with certain drugs to help lessen cancer pain or nausea and vomiting.
The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.
Occurring or existing at the same time as something else. In medicine, it may refer to a condition a person has or a medication a person is taking that is not being studied in the clinical trial he or she is taking part in.
Conflict of Interest Committee
A conflict of interest occurs when those involved with the conduct, reporting, oversight, or review of research also have personal, professional, or financial interests from which they can benefit, depending on the results of the research. Mary Crowley has established an independent committee to review any potential conflicts of interest in the conduct of their research studies.
Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. It is designed to begin the informed consent process, which consists of conversations between the subject and the research team. If the individual then decides to enter the trial, he or she gives his or her official consent by signing the document.
Contract Research Organization
A company hired by another company or research center to take over certain parts of running a clinical trial. The company may design, manage, and monitor the trial and analyze the results. Also called CRO.
Core Needle Biopsy
A biopsy, using a hollow needle to collect a small cylinder (core) tissue sample. Also called core biopsy.
A compound that is excreted from the body in urine. Creatinine levels are measured to monitor kidney function.
Computed tomography angiogram: An x-ray of blood vessels after injection of a dye.
Computerized Axial Tomography Scan is an x-ray procedure that combines many x-ray images with the aid of a computer to generate cross-sectional views and, if needed, three-dimensional images of the internal organs and structures of the body. A CT scan is used to define normal and abnormal structures in the body and/or assist in procedures by helping to accurately guide the placement of instruments or treatments.
A type of protein that is made by certain immune and non-immune cells and has an effect on the immune system. Some cytokines stimulate the immune system and others slow it down. They can also be made in the laboratory and used to help the body fight cancer, infections, and other diseases. Examples of cytokines are interleukins, interferons, and colony-stimulating factors (filgrastim, sargramostim).
Data Monitoring Committee
Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. NOTE: A DMC can stop a trial if it finds toxicities or if treatment is proved beneficial. [After FDA guidance on establishment and operation of clinical trial data monitoring committees]
A DCE-MRI is a special form of MRI scan that focuses on tumors and helps to assess blood flow to that specific area.
Surgical removal of as much of a tumor as possible. Debulking may increase the chance that chemotherapy or radiation therapy will kill all the tumor cells. It may also be done to relieve symptoms or help the patient live longer. Also called tumor debulking.
A special type of immune cell that is found in tissues, such as the skin, and boosts immune responses by showing antigens on its surface to other cells of the immune system. A dendritic cell is a type of phagocyte and a type of antigen-presenting cell (APC).
Office visit with a dermatologist to assess the status of skin, hair, and/or nails.
An imaging test that measures bone density (the amount of bone mineral contained in a certain volume of bone) by passing x-rays with two different energy levels through the bone. It is used to diagnose osteoporosis (decrease in bone mass and density). Also called BMD scan, bone mineral density scan, DEXA, dual energy x-ray absorptiometric scan, dual x-ray absorptiometry, and DXA.
Cancer that continues to grow or spread.
The return of a sign, symptom, or disease after a remission. The reappearance of cancer cells at the same site or in another location is, unfortunately, a familiar form of recurrence.
The molecules inside cells that carry genetic information and pass it from one generation to the next. Also called deoxyribonucleic acid.
A sound-wave picture to look at the veins in the patient's legs to see if he or she has any blood clots.
Dose Escalation Study
Research design in which the amount of the investigational drug or agent will be increased in each group of research participants, to find the maximum tolerated dose of the investigational drug that can be given safely without severe side effects.
Describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
A clinical trial in which the medical staff, the patient, and the people who analyze the results do not know the specific type of treatment the patient receives until after the clinical trial is over.
Drug Development Process
The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.
Electrocardiogram. Tracing of the electrical activity of the heart.
Echocardiogram. A procedure that uses ultrasonic waves directed over the chest wall to obtain a graphic record of the heart's position, motion of the walls, or internal parts such as the valves.
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The ECOG scores range from 0 to 5. A lower score means the patient is better able to carry out daily activities. ECOG may be used to determine a patient's prognosis, to measure changes in a patient’s ability to function, or to decide if a patient could be included in a clinical trial. Also called The Eastern Cooperative Oncology Group Performance Status.
The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed.
Electronic Medical Records (EMRs)
An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs may serve as source documents, and such data could also serve as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements.
A non-surgical procedure that uses an endoscope to examine the inside of the body (digestive track). An endoscope is a thin, tube-like instrument with a light and a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for signs of disease.
In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.
A protein that speeds up chemical reactions in the body.
A type of immune cell that has granules (small particles) with enzymes that are released during infections, allergic reactions, and asthma. An eosinophil is a type of white blood cell and a type of granulocyte.
The ETS (E-twenty six) family is one of the largest families of transcription factors and is unique to metazoans.
The EWS (EWSR1) gene is involved in translocations in Ewing's sarcoma, clear cell sarcoma, desmoplastic small round cell tumor, and myxoid liposarcoma.
Removal by surgery.
Functional Assessment of Cancer Therapy-Lung Cancer Subscale Form. A very short questionnaire about how the patient is feeling and what symptoms he or she has.
A test in which radioactive glucose is injected into the vein. This is taken up by the active cells in the body. It may show sites of cancer in the body.
Fine-Needle Aspiration Biopsy
A biopsy that uses a thin needle to collect a tissue sample for examination.
The first Phase I study in which the test product is administered to human beings.
F-MISO PET Scan
A scan used to detect areas of tumor that have low oxygen levels.
Food and Drug Administration
The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
A gene made by joining parts of two different genes. Fusion genes may occur naturally in the body by transfer of DNA between chromosomes. For example, the BCR-ABL gene found in some types of leukemia is a fusion gene. Fusion genes can also be made in the laboratory by combining genes or parts of genes from the same or different organisms.
A protein made from a fusion gene, which is created by joining parts of two different genes. Fusion genes may occur naturally in the body by transfer of DNA between chromosomes. For example, the BCR-ABL gene found in some types of leukemia is a fusion gene that makes the BCR-ABL fusion protein. Fusion genes and proteins can also be made in the laboratory by combining genes or parts of genes from the same or different organisms.
The functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA, and most genes contain the information for making a specific protein.
The insertion, alteration, or removal of genes to correct missing or defective ones that are responsible for disease development/genetic disorders.
The complete set of DNA (genetic material) in an organism. In people, almost every cell in the body contains a complete copy of the genome. The genome contains all of the information needed for a person to develop and grow. Studying the genome may help researchers understand how different types of cancer form and respond to treatment. This may lead to new ways to diagnose, treat, and prevent cancer.
The study of the complete genetic material, including genes and their functions, of an organism.
Good Clinical Practice (GCP)
A standard for design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
A substance made by the body that functions to regulate cell division and cell survival. Some growth factors are also produced in the laboratory and used in biological therapy.
Guaiac Smear Test
A test that checks for occult (hidden) blood in the stool. Small samples of stool are placed on special cards coated with a chemical substance called guaiac and sent to a doctor or laboratory for testing. A testing solution is put on the cards and the guaiac causes the stool sample to change color. If there is blood in the stool, the color changes very quickly. Blood in the stool may be a sign of colorectal cancer or other problems, such as polyps, ulcers, or hemorrhoids. Also called gFOBT, guaiac fecal occult blood test, and stool guaiac test.
A computerized x-ray that shows cross-sectional images (slices) of your brain.
Hereditary Inclusion Body Myopathy. Hereditary Inclusion Body Myopathy is categorized as a rare disease. Hereditary Inclusion Body Myopathies are a group of rare genetic disorders causing progressive muscle wasting and weakness beginning in young adults. Hereditary Inclusion Body Myopathies as a type of myopathy reflects a disease of muscle.
The study of tissues and cells under a microscope.
Humanized Monoclonal Antibody
A type of antibody made in the laboratory by combining a human antibody with a small part of a mouse or rat monoclonal antibody. The mouse or rat part of the antibody binds to the target antigen, and the human part makes it less likely to be destroyed by the body's immune system.
Human Research Protection Program
(HRPP) Ensures the ethical and fair treatment of patients taking part in clinical trials. The mission of the HRPP is to promote the rights and welfare of Mary Crowley patients, to increase the quality of clinical trials conducted, and to provide education and training to Mary Crowley study doctors and study teams.
A condition in which there is a decrease in the oxygen supply to a tissue. In cancer treatment, the level of hypoxia in a tumor may help predict the response of the tumor to the treatment.
Immune Checkpoint Inhibitor
A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better. Examples of checkpoint proteins found on T cells or cancer cells include PD-1/PD-L1 and CTLA-4/B7-1/B7-2. Some immune checkpoint inhibitors are used to treat cancer.
Suppression of the body's immune system and its ability to fight infections and other diseases. Immunosuppression may be deliberately induced with drugs, as in preparation for bone marrow or other organ transplantation, to prevent rejection of the donor tissue. It may also result from certain diseases such as AIDS or lymphoma or from anticancer drugs.
The treatment of disease using medicines that boost the body's natural immune response.
A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well INDs work and whether they are safe to use. An IND may be approved by the FDA for use in one disease or condition but still be considered investigational in other diseases or conditions. Also called experimental drug, investigational agent, investigational drug, and investigational new drug.
Independent Medical Review
A process, independent of all affected parties, to determine if a health care service is medically necessary, medically appropriate, experimental or investigational. Independent review typically occurs after all appeals mechanisms available within the health benefits plan have been exhausted. Independent medical review is often referred to as external review.
Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continued review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
A medical sub-specialty of radiology utilizing minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ system.
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. NOTE: CDISC included test articles in its definition of investigational products.
An individual who actually conducts a clinical investigation (i.e. under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team).
In the laboratory (outside the body). The opposite of in vivo (in the body).
In the body. The opposite of in vitro (outside the body or in the laboratory).
Or doctor of Jurisprudence, commonly abbreviated J.D., is the degree commonly conferred by law schools. It is required in all states except California (which includes an option called law office study) to gain Admission to the Bar. Gaining admission to the bar means obtaining a license to practice law in a particular state or in federal court.
A type of enzyme (a protein that speeds up chemical reactions in the body) that adds chemicals called phosphates to other molecules, such as sugars or proteins. This may cause other molecules in the cell to become either active or inactive. Kinases are a part of many cell processes. Some cancer treatments target certain kinases that are linked to cancer.
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The KPS scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS may be used to determine a patient's prognosis, to measure changes in a patient’s ability to function, or to decide if a patient could be included in a clinical trial. Also called Karnofsky Performance Status.
Removal of the blood to collect specific blood cells. The remaining blood is returned to the body.
A type of blood cell that is made in the bone marrow and found in the blood and lymph tissue. Leukocytes are part of the body’s immune system. They help the body fight infection and other diseases. Types of leukocytes are granulocytes (neutrophils, eosinophils, and basophils), monocytes, and lymphocytes (T cells and B cells). Checking the number of leukocytes in the blood is usually part of a complete blood cell (CBC) test. It may be used to look for conditions such as infection, inflammation, allergies, and leukemia. Also called WBC and white blood cell.
A drug preparation that contains the active drug inside very tiny, fat-like particles. This form is easier for the body to absorb and allows more drug to get to the target area of the body, such as a tumor. Liposomal drugs may have fewer side effects and work better than other forms of the drug.
A test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of DNA from tumor cells that are in the blood. A liquid biopsy may be used to help find cancer at an early stage. It may also be used to help plan treatment or to find out how well treatment is working or if cancer has come back. Being able to take multiple samples of blood over time may also help doctors understand what kind of molecular changes are taking place in a tumor.
A type of immune cell that is made in the bone marrow and is found in the blood and in lymph tissue. The two main types of lymphocytes are B lymphocytes and T lymphocytes. B lymphocytes make antibodies, and T lymphocytes help kill tumor cells and help control immune responses. A lymphocyte is a type of white blood cell.
A type of white blood cell that surrounds and kills microorganisms, removes dead cells, and stimulates the action of other immune system cells.
Cancerous. Malignant cells can invade and destroy nearby tissue and spread to other parts of the body.
A type of white blood cell.
A tumor that can be accurately measured in size. This information can be used to judge response to treatment.
Questions asked about a patient's past and current health problems, family's medical history, social situation/occupation, and all current medications.
The spread of cancer cells from the place where they first formed to another part of the body. In metastasis, cancer cells break away from the original (primary) tumor, travel through the blood or lymph system, and form a new tumor in other organs or tissues of the body. The new, metastatic tumor is the same type of cancer as the primary tumor. For example, if breast cancer spreads to the lung, the cancer cells in the lung are breast cancer cells, not lung cancer cells. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).
A change that occurs in the DNA of certain cells (such as tumor cells) in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different than the number of repeats that was in the DNA when it was inherited. The cause of microsatellite instability may be a defect in the ability to repair mistakes made when DNA is copied in the cell. Also called MSI.
The process by which a single parent cell divides to make two new daughter cells. Each daughter cell receives a complete set of chromosomes from the parent cell. This process allows the body to grow and replace cells.
Sub-discipline of immunology which investigates the molecular interaction involved in antigen recognition and processing, antibody-antigen interactions, cell-cell interactions, cell death, etc.
A series of actions among molecules in a cell that leads to a certain end point or cell function.
Molecular Targeted Therapy
In cancer treatment, substances that kill cancer cells by targeting key molecules involved in cancer cell growth.
In medicine, a laboratory test that checks for certain genes, proteins, or other molecules in a sample of tissue, blood, or other body fluid. Molecular tests also check for certain changes in a gene or chromosome that may cause or affect the chance of developing a specific disease or disorder, such as cancer. A molecular test may be done with other procedures, such as biopsies, to help diagnose some types of cancer. It may also be used to help plan treatment, find out how well treatment is working, or make a prognosis.
The smallest particle of a substance that has all of the physical and chemical properties of that substance. Molecules are made up of one or more atoms. If they contain more than one atom, the atoms can be the same (an oxygen molecule has two oxygen atoms) or different (a water molecule has two hydrogen atoms and one oxygen atom). Biological molecules, such as proteins and DNA, can be made up of many thousands of atoms.
A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. There are many kinds of monoclonal antibodies. A monoclonal antibody is made so that it binds to only one substance. Monoclonal antibodies are being used to treat some types of cancer. They can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells.
Uses magnetic energy to make pictures of organs and structures inside the body.
A type of RNA found in cells. mRNA molecules carry the genetic information needed to make proteins. They carry the information from the DNA in the nucleus of the cell to the cytoplasm where the proteins are made. Also called messenger RNA.
The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found. Also called maximum tolerated dose.
A multigated acquisition (MUGA) scan creates video images of the lower chambers of the heart that hold blood (called “ventricles”) to check whether they are pumping blood properly. It shows any abnormalities in the size of the ventricles and in the movement of the blood through the heart. Other names for this test include cardiac blood pooling imaging, nuclear heart scan, nuclear ventriculography, and radionuclide ventriculography.
Clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more that one investigator.
Of or relating to a murid genus (Mus) or its subfamily (Murinae) which includes the common household rats and mice.
Nanoparticles for the purpose of drug delivery are defined as submicron (< 1µm) colloidal particles. This definition includes monolithic nanoparticles (nanospheres) in which the drug is adsorbed, dissolved, or dispersed throughout the matrix and nanocapsules in which the drug is confined to an aqueous or oily core surrounded by a shell-like wall. Nanoparticles are made from biocompatible and biodegradable materials such as polymers, either natural (e.g., gelatin, albumin) or synthetic (e.g., polylactides, polyalkylcyanoacrylates), or solid lipids. In the body, the drug loaded in nanoparticles is usually released from the matrix by diffusion, swelling, erosion, or degradation.
NCI, part of the National Institutes of Health of the United States Department of Health and Human Services, is the federal government's principal agency for cancer research. It conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Also called National Cancer Institute.
Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy.
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Neoplasms may be benign (not cancer), or malignant (cancer). Also called tumor.
Simple questions and tests to check brain, spinal cord and nerve function.
A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).
A type of immune cell that is one of the first cell types to travel to the site of an infection. Neutrophils help fight infection by ingesting microorganisms and releasing enzymes that kill the microorganisms. A neutrophil is a type of white blood cell, a type of granulocyte, and a type of phagocyte.
New Drug Application (NDA)
An application to FDA for a license to market a new drug in the United States.
A federal agency in the U.S. that conducts biomedical research in its own laboratories; supports the research of non-federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helps in the training of research investigators; and fosters communication of medical information. Also called National Institutes of Health.
A type of immune cell that has granules (small particles) with enzymes that can kill tumor cells or cells infected with a virus. An NK cell is a type of white blood cell. Also called natural killer cell and NK-LGL.
A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).
A special scan that can tell the study doctor where Octreotide is most beneficial in a person's body. It is an image that can help find primary and metastatic neuroendocrine tumors inside the body.
A gene that is a mutated (changed) form of a gene involved in normal cell growth. Oncogenes may cause the growth of cancer cells. Mutations in genes that become oncogenes can be inherited or caused by being exposed to substances in the environment that cause cancer.
A type of virus that infects and lyses (breaks down) cancer cells but not normal cells. Oncolytic viruses can occur naturally or can be made in the laboratory by changing other viruses. Certain oncolytic viruses are being studied in the treatment of cancer. They may make it easier to kill tumor cells with chemotherapy and radiation therapy.
Open to Enrollment
The status of a study such that a subject can be enrolled into that study. NOTE: Registry terminology in common use is "open to recruitment"; however, recruitment can begin upon IRB approval of the site; whereas enrollment requires availability of study supplies, subject informed consent, etc., to allow participation of eligible subjects.
Orphan Drug Designation
A status given to certain drugs called orphan drugs, which show promise in the treatment, prevention, or diagnosis of orphan diseases. An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan diseases are often serious or life threatening. In 1983, the U.S. government passed a law, called the Orphan Drug Act, to give drug companies certain financial benefits for developing orphan drugs. This law is meant to help bring more drugs to patients with rare diseases.
In biology, to make too many copies of a protein or other substance. Overexpression of certain proteins or other substances may play a role in cancer development.
A procedure in which a thin needle or tube is put into the abdomen to remove fluid from the peritoneal cavity (the space within the abdomen that contains the intestines, the stomach, and the liver).
A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.
Is the evaluation of creative work or performance by other people in the same field in order to maintain or enhance the quality of the work or performance in that field.
A measure of how well daily activities can be carried out.
A form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease. In cancer, personalized medicine uses specific information about a person’s tumor to help diagnose, plan treatment, find out how well treatment is working, or make a prognosis. Examples of personalized medicine include using targeted therapies to treat specific types of cancer cells, such as HER2-positive breast cancer cells, or using tumor marker testing to help diagnose cancer. Also called precision medicine.
The combining of all different types of data (clinical, environmental and genetic) to identify medical treatments that will work for that specific person.
Positron Emission Scan. A test in which the radioactive glucose is injected into the vein. This is taken up by active cells in the body. It may show sites of cancer in the body.
Pharmacodynamic Blood Sampling
Also known as Biomarker Blood Sampling. Pharmacodynamic/Biomarker blood samples will be drawn to measure how a study drug or agent is acting on the body.
Pharmacogenetic Blood Sampling
Pharmacogenetic blood samples will be drawn to study how the genes and DNA may cause the body to react to or handle drugs differently than another person treated with the same study drug or agent.
Pharmacokinetic Blood Sampling
Pharmacokinetic blood samples will be drawn to measure how long a study drug or agent stays in the blood.
Phase I Clinical Trial
The initial introduction of an investigational new drug into humans. Phase I studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase I, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase II studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase I studies also include studies of metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.
Phase II Clinical Trial
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase II studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.
Phase III Clinical Trial
A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, Phase III clinical trials may compare which group of patients has better survival rates or fewer side effects. In most cases, treatments move into Phase III trials only after they meet the goals of phase I and II trials. Phase III clinical trials may include hundreds of people.
Phase VI Clinical Trial
A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time. Phase IV clinical trials may include thousands of people. Also called post-marketing surveillance trial.
An inactive product that looks the same as the study drug or agent. Placebos are used in clinical trials to allow study doctors to compare the benefits and side effects of the study drug or agent to those with no treatment.
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.
For female patients who could possibly become pregnant, the blood or urine will be tested to make sure she is not pregnant.
Primary Care Doctor
A doctor who manages a person's health care over time. A primary care doctor is able to give a wide range of care, including prevention and treatment, can discuss cancer treatment choices, and can refer a patient to a specialist.
An attempt to prevent disease.
A molecule made up of amino acids. Proteins are needed for the body to function properly. They are the basis of body structures, such as skin and hair, and of other substances such as enzymes, cytokines, and antibodies.
The study of the structure and function of proteins, including the way they work and interact with each other inside cells.
A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what information will be collected.
Pulmonary Function Test (PFT)
A test used to measure how well the lungs work. It measures how much air the lungs can hold and how quickly air is moved into and out of the lungs. It also measures how much oxygen is used and how much carbon dioxide is given off during breathing. A pulmonary function test can be used to diagnose a lung disease and to see how well treatment for the disease is working. Also called lung function test and PFT.
Monitoring the oxygen level in the blood.
A procedure in which a small round piece of tissue about the size of a pencil eraser is removed using a sharp, hollow, circular instrument. The tissue is then checked under a microscope for signs of disease. A punch biopsy may be used to check for certain types of cancer, including skin, vulvar, and cervical cancer. It may also be used to check for certain skin conditions and changes that may lead to cancer.
Recombinant DNA Advisory Committee. The Recombinant DNA Advisory Committee is a panel of up to 21 national experts in various fields of science, medicine, genetics, ethics, and patient perspectives that considers the current state of knowledge and technology regarding recombinant DNA research.
An unstable form of a chemical element that releases radiation as it breaks down and becomes more stable. Radioisotopes may occur in nature or be made in a laboratory. In medicine, they are used in imaging tests and in treatment.
Randomized Clinical Trial
Research design in which participants are assigned to receive the study drug or agent or standard of care therapy already approved for a certain type of disease. The assignment is random; similar to flipping a coin. In some cases, the study doctor and the research participant may not be able to choose or may not know which group the patient has been assigned to; however, the information is available if needed because of a medical emergency. Randomized clinical trials are conducted to allow study doctors to compare the benefits and side effects of the two regimens.
A standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger. To use RECIST, there must be at least one tumor that can be measured on x-rays, CT scans, or MRI scans. The types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (SD). Also called Response Evaluation Criteria In Solid Tumors.
In medicine, the act of a doctor in which a patient is sent to another doctor for additional healthcare services.
In medicine, describes a disease or condition that does not respond to treatment.
A decrease in the size of a tumor or in the extent of cancer in the body.
Research Advocacy Network
The Research Advocacy Network’s overall goal is to channel advocates’ passion into effective interactions with the research community. The Advocate Institute is designed to help build advocates’ understanding of the medical research system, scientific concepts and safeguards for research participants; it is geared for volunteers with varying degrees of knowledge. The RAN offers on-site training as well as online learning resources for advocates who are often geographically dispersed.
Able to be removed with surgery.
Cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment, or it may become resistant during treatment. Also called refractory cancer.
A type of cancer that begins in bone or in the soft tissues of the body, including cartilage, fat, muscle, blood vessels, fibrous tissue, or other connective or supportive tissue. Different types of sarcoma are based on where the cancer forms. For example, osteosarcoma forms in bone, liposarcoma forms in fat, and rhabdomyosarcoma forms in muscle. Treatment and prognosis depend on the type and grade of the cancer (how abnormal the cancer cells look under a microscope and how quickly the cancer is likely to grow and spread). Sarcoma occurs in both adults and children.
Scientific Review Committee
A group of doctors, scientists, and other experts that reviews the detailed plan of a clinical trial for scientific quality and correct study design. There is a scientific review committee at every health care facility that does clinical research. Most clinical trials are reviewed by the scientific review committee before they go to the facility’s Institutional Review Board (IRB) for approval. Also called scientific review panel.
In medicine, the opinion of a doctor other than the patient’s current doctor. The second doctor reviews the patient’s medical records and gives an opinion about the patient’s health problem and how it should be treated. A second opinion may confirm or question the first doctor’s diagnosis and treatment plan, give more information about the patient’s disease or condition, and offer other treatment options.
A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
Describes a group of molecules in a cell that work together to control one or more cell functions, such as cell division or cell death. After the first molecule in a pathway receives a signal, it activates another molecule. This process is repeated until the last molecule is activated and the cell function is carried out. Abnormal activation of signaling pathways can lead to cancer, and drugs are being developed to block these pathways. These drugs may help block cancer cell growth and kill cancer cells.
A substance that is able to enter cells easily because it has a low molecular weight. Once inside the cells, it can affect other molecules, such as proteins, and may cause cancer cells to die. This is different from drugs that have a large molecular weight, such as monoclonal antibodies, which are not able to get inside cells very easily. Many targeted therapies are small-molecule drugs or small molecule inhibitors.
A professional trained to talk with people and their families about emotional or physical needs, and to find them support services.
An alteration in DNA that occurs after conception. Somatic mutations can occur in any of the cells of the body except the germ cells (sperm and egg) and therefore are not passed on to children. These alterations can (but do not always) cause cancer or other diseases.
Spiral CT Scan
A procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The x-ray machine scans the body in a spiral path. This allows more images to be made in a shorter time than with older CT methods. A dye may be injected into a vein or swallowed to help the organs or tissues show up more clearly on the x-ray. Spiral CT scan also creates more detailed pictures and may be better at finding small abnormal areas inside the body. It may be used to help diagnose disease, plan treatment, or find out how well treatment is working. Also called helical computed tomography.
Spitzer Quality of Life Index
A brief assessment of quality of life.
Flat cell that looks like a fish scale under a microscope. These cells are found in the tissues that form the surface of the skin, the passages of the respiratory and digestive tracts, and the lining of the hollow organs of the body (such as the bladder, kidney, and uterus, including the cervix).
Cancer that is neither decreasing nor increasing in extent or severity.
Standard of Care
Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.
Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of supportive care is to prevent or treat as early as possible the symptoms of a disease, side effects caused by treatment of a disease, and psychological, social, and spiritual problems related to a disease or its treatment. Also called comfort care, palliative care, and symptom management.
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
One who remains alive and continues to function during and after overcoming a serious hardship or life-threatening disease. In cancer, a person is considered to be a survivor from the time of diagnosis until the end of life.
Having to do with symptoms, which are signs of a condition or disease.
Having to do with substances that are man-made instead of taken from nature.
Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.
A combination of biochemistry, proteomics, genomics, metabolomics, and bioinformatics used to better understand the contribution of each element of the system to the whole. In proteomics and cancer, perturbations in the protein component of signal transduction systems, for example, can lead to cell and tissue changes that promote tumorigenesis.
Rapid beating of the heart, usually defined as greater than 100 beats per minute.
A type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells. Other types of targeted therapies help the immune system kill cancer cells or deliver toxic substances directly to cancer cells and kill them. Targeted therapy may have fewer side effects than other types of cancer treatment. Most targeted therapies are either small molecule drugs or monoclonal antibodies.
A type of white blood cell. T cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and may help fight cancer. Also called T lymphocyte and thymocyte.
Removal of fluid from the pleural cavity through a needle inserted between the ribs.
A condition in which there is a lower-than-normal number of platelets in the blood. It may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.
A group or layer of cells that work together to perform a specific function.
A system to describe the amount and spread of cancer in a patient’s body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). This system was created and is updated by the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC). The TNM staging system is used to describe most types of cancer. Also called AJCC staging system.
Texas Oncology Physicians Association is a statewide network of physicians and healthcare professionals exclusively dedicated to serving oncology patients.
A term used to describe the process by which the results of research done in the laboratory are used to develop new ways to diagnose and treat disease.
In medicine, a course of treatment that is repeated on a regular schedule with periods of rest in between. For example, treatment given for one week followed by three weeks of rest is one treatment cycle.
A detailed plan with information about a patient’s disease, the goal of treatment, the treatment options for the disease and possible side effects, and the expected length of treatment. A treatment plan may also include information about how much the treatment is likely to cost and about regular follow-up care after treatment ends.
A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-reg.
A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called clinical trial sponsor.
A procedure where the skin is cleaned, and then numbing medicine is given using a small needle. A larger needle is inserted to remove a small sample of tissue. Gentle pressure is applies to stop any bleeding and then a small dressing is used to cover the biopsy site. Stitches may be required. Risks include temporary swelling, pain, bleeding, infection, and scarring.
Tumor Board Review
A treatment planning approach in which a number of doctors who are experts in different specialties (disciplines) review and discuss the medical condition and treatment options of a patient. In cancer treatment, a tumor board review may include that of a medical oncologist (who provides cancer treatment with drugs), a surgical oncologist (who provides cancer treatment with surgery), and a radiation oncologist (who provides cancer treatment with radiation). Also called multidisciplinary opinion.
A substance found in tissue, blood, or other body fluids that may be a sign of cancer or certain benign (noncancerous) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer).
A protein or other molecule that is unique to cancer cells or is much more abundant in them. These molecules are usually found in the plasma (outer) membrane, and they are thought to be potential targets for immunotherapy or other types of anticancer treatment.
Tumor Suppressor Gene
A type of gene that makes a protein called a tumor suppressor protein that helps control cell growth. Mutations (changes in DNA) in tumor suppressor genes may lead to cancer. Also called antioncogene.
A procedure that uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram). Ultrasound may be used to help diagnose diseases, such as cancer. It may also be used during pregnancy to check the fetus (unborn baby) and during medical procedures, such as biopsies. Also called ultrasonography.
Unable to be removed with surgery.
A test that determines the content of the urine.
A urine sample for routine tests.
A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. A vaccine can help the body recognize and destroy cancer cells or microorganisms.
Treatment using a virus that has been changed in the laboratory to find and destroy cancer cells without harming healthy cells. It is a type of targeted therapy. Also called oncolytic virotherapy, oncolytic virus therapy, and virotherapy.
A type of virus used in cancer therapy. The virus is changed in the laboratory and cannot cause disease. Viral vectors may produce tumor antigens (proteins found on a tumor cell) to stimulate an antitumor immune response in the body. Viral vectors may also be used to carry genes that can change cancer cells back to normal cells.
Comprised of height, weight, temperature, blood pressure, heart rate, and breathing rate readings.
A type of blood cell that is made in the bone marrow and found in the blood and lymph tissue. WBCs are part of the body’s immune system. They help the body fight infection and other diseases. Types of WBCs are granulocytes (neutrophils, eosinophils, and basophils), monocytes, and lymphocytes (T cells and B cells). Checking the number of WBCs in the blood is usually part of a complete blood cell (CBC) test. It may be used to look for conditions such as infection, inflammation, allergies, and leukemia. Also called leukocyte and white blood cell.
Western Internal Review Board (WIRB)
The Western Institutional Review Board (WIRB) was founded in 1968 to provide human subject protection in research. Today, WIRB offers review services for more than 400 institutions, all major sponsors, most Contract Research Organizations (CROs), coordinating groups, and individual investigators—in all 50 states and around the world.
An authoritative report on a major issue, as by a team of journalists.
A type of radiation used in the diagnosis and treatment of cancer and other diseases. In low doses, x-rays are used to diagnose diseases by making pictures of the inside of the body. In high doses, x-rays are used to treat cancer.