Clinical Trials - Glossary of Terms

Term Definition
3-dimensional conformal radiation therapy (3D-CRT) A procedure that uses a computer to create a 3-dimensional picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Also called 3-dimensional radiation therapy.
Adjuvant therapy Treatment given after or in conjunction with the primary treatment to increase the chances of a cure. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy or biological therapy.
Anti-emetic A drug that reduces or prevents nausea and vomiting.
Antigen A substance that promotes the production of antibodies.
Benign A term that means not cancerous. The infection does not invade nearby tissue or spread to other parts of the body.
Biological therapy A treatment to stimulate or restore the ability of the immune system to fight infection and disease. The therapy is used to lessen side effects that may be caused by some cancer treatments. Biological therapy can also be called immunotherapy or biological response modifier (BRM) therapy.
Biomarkers Substances sometimes found in an increased amount in the blood, other body fluids or tissues and which can be used to indicate the presence of some types of cancer. Biomarkers include CA 125 (ovarian cancer), CA 15-3 (breast cancer), CEA (ovarian, lung, breast, pancreas, and GI tract cancers) and PSA (prostate cancer).
Biopsy The removal of cells or tissues for examination under a microscope. When only a sample of tissue is removed, the procedure is called an incisional biopsy or core biopsy. When the whole tumor is removed, the procedure is called an excisional biopsy. When a sample of tissue or fluid is removed with a needle, the procedure is called a needle biopsy or fine-needle aspiration.
Bone marrow biopsy The removal of a sample of tissue from the bone marrow with a needle for examination under a microscope.
Brachytherapy A procedure in which radioactive material sealed in needles, seeds, wires or catheters is placed directly into or near a tumor. Also called internal radiation, implant radiation or interstitial radiation therapy.
CALGB An acronym for Cancer and Acute Leukemia Group B.
Catheter A flexible tube used to deliver fluid into or withdraw fluids from the body.
CEA An acronym for cost effectiveness analysis, also a blood tumor marker.
Chemotherapy The use of drugs to treat people with cancer.
Clinical cooperative group <i>See cooperative group.</i>
Clinical research associate (CRA) An employee qualified by training and experience to monitor a clinical trial. CRAs are responsible for assuring clinical trials are conducted according to procedures and government regulations. The CRA collects data, ensures eligibility requirements have been met and submits data to the appropriate agences. CRAs also follow up with all patients who have been enrolled in clinical tirals.
Clinical trial A research study that evaluates the effectiveness of new interventions in people. Each study is designed to evaluate new methods of screening, prevention, diagnosis or treatment of cancer.
Complete blood count (CBC) A test to check the number of red blood cells, white blood cells and platelets in a sample of blood. Also called blood cell count.
Complete response A tumor(s) that has disappeared as a result of therapy.
Computerized tomography (CT scan) A series of detailed pictures of areas inside the body taken from different angles. A computer linked to an x-ray machine creates the pictures. This is also called computed tomography and computerized axial tomography (CAT) scan.
Consent form See informed consent.
Control group A group of people in a clinical trial that receive standard treatment for their cancer. (See treatment group.)
Cooperative group A group of physicians, hospitals, or both formed to treat a large number of persons in the same way so that a new treatment can be evaluated quickly. Clinical trials of new cancer treatments often require many more people than a single physician or hospital can care for.
Double-blinded study A clinical trial in which neither the medical staff nor the patient knows if the patient is receiving the investigational drug, another drug or a placebo.
Dysphagia A term to describe difficulty in swallowing.
Dysplasia Abnormal changes in the way tissue cells look under a microscope.
Dyspnea A term to describe shortness of breath.
Eastern Cooperative Oncology Group (ECOG) One of the largest clinical cancer research organizations in the United States, and conducts clinical trials in all types of adult cancers.
Endoscopy The use of a thin, lighted tube (endoscope) to examine the inside of the body.
Estrogens A family of hormones that promote the development and maintenance of female sex characteristics.
Excision Removal by surgery.
External radiation Radiation therapy that uses a machine to aim high-energy rays at the cancer. This is also called external-beam radiation.
Familial cancer A cancer, or a predisposition toward cancer, that runs in families.
Family history A record of a person's current and past illnesses, those of his or her parents, brothers, sisters, children and other family members. A family history shows the pattern of certain diseases in a family, and helps to determine risk factors for those and other diseases.
FDA An acronym for Food and Drug Administration, an agency of  United States Department of Health and Human Services(DHHS).
Hereditary nonpolyposis colon cancer (HNPCC) An inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. Also called Lynch syndrome.
Hormone therapy Treatment that removes, blocks or adds hormones. This is also called endocrine therapy, hormonal therapy or hormone treatment.
Hormones Chemicals produced by glands in the body and circulated in the bloodstream. Hormones control the actions of certain cells or organs.
Immune system The complex group of organs and cells that defends the body against infection or disease.
Immunotherapy Treatment to stimulate or restore the ability of the person's immune system to fight infection and disease. Immunotherapy is used to lessen side effects that may be caused by some cancer treatments. Also called biological therapy or biological response modifier (BRM) therapy.
Incision A cut made in the body to perform surgery.
Informed consent The process in which a person learns key facts about a clinical trial or research study and then agrees voluntarily to take part or decides against it. This process includes signing a form that describes the benefits and risks that may occur if the person decides to take part.
Institutional Review Board (IRB) A group of doctors, nurses, scientists and knowledgeable lay people who review studies such as clinical trials before they begin to ensure that potential benefits outweigh the risks. The board's role is to protect the rights and welfare of any person who participates in research or a clinical study. This group also monitors data during the studies to ensure the treatment's effectiveness.
Interferons These biological response modifiers are substances that can improve the body's natural response to disease. Interferons interfere with the division of cancer cells and thus slow the growth of the tumor. There are several types of interferons, including interferon alfa, beta and gamma. The body normally produces these substances. They are also made in the laboratory for use in treating cancer and other diseases.
Interleukin-2/IL-2 A type of biological response modifier (substance that can improve the body's natural response to disease) that stimulates the growth of certain disease-fighting blood cells in the immune system. The body normally produces these substances. They are also made in the laboratory for use in treating cancer and other diseases. Also called aldesleukin.
Internal radiation A procedure in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor. Also called brachytherapy, implant radiation, or interstitial radiation therapy.
Intravenous (IV) A needle inserted into a blood vessel that allows medication and other liquids to enter the body.
Investigator A researcher in a treatment study.
Local therapy A treatment that affects cells in the tumor and the area close to it.
Lymph node A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. This is also known as a lymph gland. Lymph nodes are spread out along lymphatic vessels and contain many lymphocytes, which filter the lymphatic fluid (lymph).
Lymphatic system The tissues and organs that produce, store and carry white blood cells that fight infection and other diseases. This system includes the bone marrow, spleen, thymus, lymph nodes and network of thin channels that carry lymph and white blood cells. These channels, like blood vessels, branch into all the tissues of the body.
Magnetic resonance imaging (MRI) A procedure in which a magnet linked to a computer is used to create detailed pictures of areas inside the body.
Maintenance therapy Treatment that is used to prevent a recurrence in patients who are in remission.
Malignant Meaning cancerous, a growth with a tendency to invade and destroy nearby tissue and spread to other parts of the body.
Medical oncologist A doctor who specializes in diagnosing and treating people with cancer and often serves as the main physician for someone who has cancer, coordinating the treatment provided by other specialists.
Metastatic Cancer that spread from a primary tumor to another part of the body.
Monoclonal antibodies Laboratory-produced substances that can locate and bind to cancer cells wherever they are in the body. Many monoclonal antibodies are used in cancer detection or therapy. Each of these antibodies recognizes a different protein on specific cancer cells. Monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins or radioactive material directly to a tumor.
Multimodality therapy A therapy that combines more than one method of treatment such as chemotherapy and radiation.
Myleosuppresion Suppression of blood cell production.
National Cancer Institute (NCI) As part of the National Institutes of Health of the United States Department of Health and Human Services, NCI is the Federal Government's principal agency for cancer research. NCI conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer.
Neoadjuvant therapy Treatment given before or in conjunction with the primary treatment. Neoadjuvant therapy may include chemotherapy, radiation therapy or hormone therapy given before surgery.
Nerotoxicity Damage to the nervous system caused by some treatments.
Neuropathy A malfunction of the nerves sometimes caused by chemotherapy; numbness and weakness are common symptoms.
Oncologist A doctor who specializes in treating cancer.
Oncology The study of cancer.
Palliative treatment A treatment to reduce symptoms rather than to cure.
Partial response (PR) Tumors that have shrunk but have not disappeared as a result of treatment.
Pathologist A doctor who identifies diseases by studying cells and tissues under a microscope.
Performance scale A score from 0 to 100 that conveys a patient's ability to function and perform normal daily activities, where 100 indicate completely normal functioning.
Pilot study A treatment administered to a small group of patients to learn if it will be effective and safe on a broad scale.
Placebo A tablet, capsule or injection that looks like the drug or other substance being tested but contains no drug.
Platelet A type of blood cell that helps prevent bleeding by causing blood clots to form. Also called a thrombocyte.
Positron Emission Tomography (PET) A procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body.
Principal investigator (PI) A physician who oversees all aspects of a clincial trial, such as concept developemnt, protocol writing, protocol submission for IRB approval, participant recruitment and the informed consents. The PI also manages the data collection, analysis, interpretation and presenation.
Progesterone A female hormone.
Prognosis The likely outcome or course of a disease, the chance of recovery.
Protocol An action plan for a clinical trial. The plan states what will be done in the study and why. It outlines how many people will take part in the study, what types of patients may take part, what tests they will receive and how often, and the treatment plan.
Protocol coordinator A nurse who is responsible for assuring clinical trials are conducted according to procedures and government regulations. The nurse meets with prospective clinical trial patients to review the informed consent and make sure eligibility requirements have been met.
Quality of life (QOL) The overall enjoyment of life. Many clinical trials measure aspects of a person's sense of well-being and ability to perform various tasks in order to assess the effects that cancer and its treatment have on the person.
Radiation oncologist A doctor who specializes in using radiation to treat people with cancer.
Radiation therapy Also called radiotherapy, this treatment uses high-energy radiation from X-rays, gamma rays and other radiation sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam or conformal radiation therapy) or it may come from radioactive material placed in the body in the area near cancer cells (internal radiation therapy, radiation implants or brachytherapy).
Radiation Therapy Oncology Group (RTOG) A national clinical cooperative group funded by the National Cancer Institute (NCI) since 1968 to increase the survival and improve the quality of life of patients diagnosed with cancer. The primary areas of research for RTOG investigators are: brain tumors, head and neck cancer, lung cancer, cancers of the gastrointestinal system (esophagus, rectum, anal canal and stomach), genitourinary tract cancers (bladder and prostate), sarcomas, gynecologic cancer (cervix) and breast cancer. The Group consists of both clinical and laboratory investigators from more than 260 institutions across the United States and Canada and includes in its membership nearly 90% of all NCI-designated comprehensive and clinical cancer centers.
Radiofrequency ablation The use of electrodes to heat and destroy abnormal tissue.
Randomization A method used to prevent bias in research. People are assigned by chance to either the treatment or control group. You and your doctor will NOT be able to choose which treatment you receive.
Recurrent cancer Cancer that has returned after a period of time during which the cancer could not be detected. The cancer may come back to the same site as the original (primary) tumor or to another place in the body.
Regimen A plan that outlines the dosage, schedule and duration of treatment.
Regression A reduction in symptoms or disease process.
Relapse A reappearance of disease after it has disappeared.
Remission When the signs and symptoms of cancer go away, the disease is said to be "in remission". A remission can be temporary or permanent.
Risk factor Something that may increase the chance of developing a disease. Some examples of risk factors for cancer include age, a family history of certain cancers, use of tobacco products, certain eating habits, obesity, exposure to radiation or other cancer-causing agents, and certain genetic changes.
Side effect A problem that occur when treatment affects healthy cells. Common side effects of standard cancer treatments are fatigue, nausea, vomiting, decreased blood cell counts, hair loss and mouth sores. New treatments being tested may have these or other unknown side effects.
Single blind study A method used to prevent bias in treatment studies. In a single blind study, the patient is not told whether he/she is taking the standard treatment or the new treatment being tested. Only the doctors know.
Stage The extent of a cancer within the body, including whether the disease has spread from the original site to other parts of the body. Staging refers to the determination of the extent of cancer.
Standard treatment The best treatment currently known for a cancer, based on results of past research.
Stereotactic radiosurgery High dose, precisely focused radiation, usually delivered in one session. The Gamma Knife is one form of radiosurgery.
Symptom An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting and pain.
Systemic To affect the entire body.
Systemic chemotherapy Treatment with anticancer drugs that travel through the bloodstream, reaching and affecting cells all over the body.
TID An acronym for three times a day.
Tissue A group or layer of cells that are alike and that work together to perform a specific function.
Translational research Refers to the progression of a new treatment from the laboratory to the clinic.
Transurethral resection of the prostate (TURP) Surgical procedure to remove tissue from the prostate using an instrument inserted through the urethra.
Treatment group The group that receives the new treatment being tested during a study. <i>See control group.</i>
Tumor An abnormal mass of tissue that results from excessive cell division. A tumor may be benign (not cancerous) or malignant (cancerous).
Ultrasonography A study in which sound waves (ultrasound) are bounced off tissues and the echoes are converted into a picture (sonogram).