Glossary

Accrual—the enrollment of qualified patients into clinical trials

Adaptive trial design—trials that incorporate one or more decision points into their design. How a trial proceeds following each decision point depends on the data observed up to that point

Adenoma—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)

Adjuvant therapy—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

Adverse event—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

Alkylating agent—a type of drug that is used in the treatment of cancer. It interferes with the cell’s DNA and inhibits cancer cell growth

All-trans retinoic acid—a nutrient that is used to treat acute promyelocytic leukemia (a fast-growing cancer in which there are too many immature



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Glossary Accrual—the enrollment of qualified patients into clinical trials Adaptive trial design—trials that incorporate one or more decision points into their design. How a trial proceeds following each decision point depends on the data observed up to that point Adenoma—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) Adjuvant therapy—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 Adverse event—an unexpected medical problem that happens during treat- ment 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 Alkylating agent—a type of drug that is used in the treatment of cancer. It interferes with the cell’s DNA and inhibits cancer cell growth All-trans retinoic acid—a nutrient that is used to treat acute promyelocytic leukemia (a fast-growing cancer in which there are too many immature 2

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20 A NATIONAL CANCER CLINICAL TRIALS SySTEM blood-forming cells in the blood and bone marrow). All-trans retinoic acid is being studied in the prevention and treatment of other types of cancer. Also called ATRA, retinoic acid, tretinoin, and vitamin A acid Analytical validation—assessing an assay and its measurement performance characteristics, determining the range of conditions under which the assay will give reproducible and accurate data Angiogenesis—blood vessel formation. Tumor angiogenesis is the growth of new blood vessels that tumors need to grow. This is caused by the release of chemicals by the tumor Annotated specimens—samples of material, such as urine, blood, tissue, cells, DNA, RNA, and protein that are associated with clinical information Antibody—a protein made by plasma cells (a type of white blood cell) in response to an antigen. Each antibody can bind to only one specific antigen Antifolate—a substance that blocks the activity of folic acid. Antifolates are used to treat cancer. Also called folate antagonist Antigen—any substance that causes the body to make a specific immune response Apoptosis—a type of cell death in which a series of molecular steps in a cell leads to death. This is the body’s normal way of getting rid of unneeded or abnormal cells. The process of apoptosis may be blocked in cancer cells. Also called programmed cell death Assay—a laboratory test to find and measure the amount of a specific substance back office operations—also called back-end processes, those operations that rarely directly interface with a customer bayesian—a trial design that considers the treatment effect as a random variable with a probability distribution rather than as an unknown constant that the investigator wishes to estimate bevicizumab (Avastin)—a monoclonal antibody used to treat several types of cancer, including certain types of colorectal, lung, breast, and kidney can- cers and glioblastoma. Bevacizumab binds to vascular endothelial growth

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21 GLOSSARy factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow bias—a systematic as opposed to random distortion of a statistic as a result of a sampling procedure biomarker—a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or phar- macologic responses to a therapeutic intervention biomarker qualification—the evidentiary process of linking a biomarker with biological processes and clinical endpoints biomedical imaging—the technique and processes used to create images of the human body for clinical purposes or medical science biorepository—a facility that collects, catalogs, and stores samples of bio- logical material, such as urine, blood, tissue, cells, DNA, RNA, and pro- tein, from humans for laboratory research. Medical information may also be stored along with a written consent to use the samples in laboratory studies biospecimen—samples of material, such as urine, blood, tissue, cells, DNA, RNA, and protein b-raf—a gene that makes a protein called B-RAF, which is involved in send- ing signals in cells and in cell growth. This gene may be mutated (changed) in many types of cancer, which causes a change in the B-RAF protein. This can increase the growth and spread of cancer cells Cancer staging—describes the extent or severity of an individual’s cancer Case report form—a paper or electronic questionnaire used to collect data from trial sites participating in a clinical trial. Case report forms include data on each patient participating in a clinical trial, including adverse events. Cervical cancer—cancer that forms in tissues of the cervix. It is usually a slow-growing cancer that may not have symptoms and is almost always caused by human papillomavirus infection Cetuximab (Erbitux)—a monoclonal antibody used to treat certain types of cancer. Cetuximab binds to the epidermal growth factor receptor (EGFR), which is found on the surface of some types of cancer cells

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22 A NATIONAL CANCER CLINICAL TRIALS SySTEM Chemoprevention—the use of drugs, vitamins, or other agents to try to reduce the risk of, or delay the development or recurrence of, cancer Chemoradiotherapy—treatment that combines chemotherapy with radia- tion therapy Chemotherapy—treatment with drugs that kill cancer cells Cisplatin (platinol)—a drug containing platinum used to treat many types of cancer. It kills cancer cells by damaging their DNA and stopping them from dividing. c-kit—a gene that makes a protein found on the surface of some cells that binds to stem cell factor (a substance that causes certain types of cells to grow). Altered forms of this receptor may be associated with some types of cancer. Also called stem cell factor receptor Clinical decision support—a clinical system, application, or process that helps health professionals make clinical decisions to enhance patient care Coinsurance—describing the joint assumption of risk between the insurer and the insured that can be represented as a percentage or as a flat rate (copayment) Colorectal cancer—cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus) Combination products—multiple therapeutic agents that are used together in a treatment, or a therapeutic agent accompanied by a diagnostic test Combination therapy—treatment using more than one anticancer drug Common Rule—the term used by 18 federal agencies that have adopted the same regulation governing the protection of human subjects of research (Subpart A of 45 Code of Federal Regulations [C.F.R.] part 46) Community-based participatory research—a collaborative approach to research, bringing community members into the research process as part- ners to develop studies and disseminate knowledge gained Comorbidity—the condition of having two or more diseases at the same time

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2 GLOSSARy Comparative effectiveness research—the conduct and synthesis of system- atic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions Computed tomography (CT)—a series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a com- puter linked to an x-ray machine Cooperative agreement—an administrative and funding instrument utilized by federal agencies to provide assistance to award recipients. Unlike grants, cooperative agreements are utilized when substantial government involve- ment is expected Cooperative Group—the collection of researchers, cancer centers, academic medical centers, community hospitals, private research institutions, and community physicians who organize to design and implement clinical trials to study new cancer treatments, methods of cancer prevention and early detection, and quality of life issues. The Cooperative Groups are adminis- tered by NCI Correlative science—a general term referring to research done on biospeci- mens that are collected during clinical trials Current Procedural Terminology (CPT)—a medical nomenclature used to report medical procedures and services under public and private health insurance programs Cyclophosphamide—a synthetic alkylating agent chemically related to the nitrogen mustards with antineoplastic and immunosuppressive activities. In the liver, cyclophosphamide is converted to the active metabolites aldo- phosphamide and phosphoramide mustard, which bind to DNA, thereby inhibiting DNA replication and initiating cell death Cytogenetic marker—chromosomal abnormalities that can be detected in cells microscopically Cytostatic—stopping cells from multiplying Cytotoxic—cell-killing Dexamethasone—a synthetic steroid used to treat leukemia and lymphoma and may be used to treat some of the problems caused by other cancers and their treatment

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM Digital mammography—the use of a computer, rather than x-ray film, to create a picture of the breast Dosimetry—measurement of radiation exposure from x-rays, gamma rays, or other types of radiation used in the treatment or detection of diseases, including cancer Doxorubicin—an anthracycline antitumor antibiotic drug that is used to treat many types of cancer by damaging DNA and cancer cells Efficacy—the ability of an intervention to produce the desired beneficial effect Eligibility criteria—requirements that must be met for an individual to be included in a clinical trial. Examples of eligibility criteria include age, type and stage of cancer, general health, and previous treatment Endometrial cancer—cancer that forms in the tissue lining of the uterus Epidermal growth factor receptor (EGFR)—the protein found on the sur- face of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor Estrogen receptor (ER)—a protein found inside the cells of the female reproductive tissue, some other types of tissue, and some cancer cells. The hormone estrogen will bind to the receptors inside the cells and may cause the cells to grow Exogenous probes—targeted contrast agents used in molecular imaging Finasteride—a drug used to reduce the amount of male hormone (testoster- one) produced by the body Flourine-18 fluorodeoxyglucose (18F-FDG)—a marker for the elevated level of glucose metabolism that occurs in most cancers Fluorouracil (5-Fu)—an antimetabolite drug used in cancer treatment. The drug may kill cancer cells by stopping cells from making DNA Formalin-fixed, paraffin-embedded tissue—a tissue sample that has been preserved to enable pathological or molecular analysis

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2 GLOSSARy Frequentist—an approach to statistical inference based on quantifying the frequency with which errors in rejecting or not rejecting a specific hypoth- esis would be made if an experiment were repeated many times Front office operations—also called front-end processes in information systems, are those operations that interface directly with the customer (in this case, patients and physicians) Gastrointestinal stromal tumor (GIST)—a type of tumor that usually begins in cells in the wall of the gastrointestinal tract Gemtuzumab ozogamicin—a monoclonal antibody combined with a toxic substance that is used to treat certain types of acute myeloid leukemia in older patients and is being studied in the treatment of other types of cancer Genome—an organism’s entire complement of DNA, which determines its genetic makeup Genomics—the study of the complete genetic material, including genes and their functions, of an organism Germline DNA—the DNA in germ cells. Germline DNA is the source of DNA for all other cells in the body Glioma—a cancer of the brain that begins in glial cells (cells that surround and support nerve cells) Glycolysis—a process in which glucose is partially broken down by cells in enzyme reactions that do not need oxygen. Glycolysis is one method that cells use to produce energy. When glycolysis is linked with other enzyme reactions that use oxygen, more complete breakdown of glucose is possible and more energy is produced Grade 1 toxicities—mild adverse events Grade 2 toxicities—moderate adverse events Grade 3 toxicities—severe adverse events Grade 4 toxicities—life-threatening or disabling adverse events Head and neck cancer—cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx)

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM Health Insurance Portability and Accountability Act of 1996 (HIPAA)—an Act that requires, among other things, under the Administrative Simplifi- cation subtitle, the adoption of standards for protecting the privacy and security of personally identifiable health information Hematologic malignancies—cancer of the blood or bone marrow, such as leukemia or lymphoma Hepatocellular carcinoma—a primary cancer of the liver Histologic subtypes—categories of cancer based on microscopic appearance of the tissue Human epidermal growth factor receptor 2 (HER-2)—a tyrosine kinase receptor, found on some types of cancer cells, including breast and ovar- ian. Cancer cells removed from the body may be tested for the presence of HER-2 to help decide the best type of treatment Hypoxia—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 Imatinib mesylate (Gleevec)—a drug used to treat different types of leuke- mia and other cancers. Imatinib mesylate blocks the protein made by the bcr/abl oncogene. It is a type of tyrosine kinase inhibitor Immunophenotyping—a process used to identify cells, based on the types of antigens or markers on the surface of the cell. This process is used to diagnose specific types of leukemia and lymphoma by comparing the cancer cells to normal cells of the immune system Immunostaining—use of an antibody-based method of detection Immunotherapy—treatment to boost or restore the ability of the immune system to fight cancer, infections, and other diseases. Also used to lessen certain side effects that may be caused by some cancer treatments. Agents used in immunotherapy include monoclonal antibodies, growth factors, and vaccines. These agents may also have a direct antitumor effect. Also called biological response modifier (BRM) therapy, biological therapy, and biotherapy In vivo—in the body

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2 GLOSSARy Incidence—the number of new cases of a disease diagnosed each year Indication—the use of a particular drug or diagnostic test for a specific disease or condition Informed consent—a legal form required by the Common Rule that describes the potential risks and benefits of research and seeks permission to involve the subject Institutional Review board (IRb)—“An administrative body established to protect the rights and welfare of human research subjects recruited to par- ticipate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modification in, or disapprove all research activities that fall within its juris- diction as specified by both the federal regulations and local institutional policy” (Department of Health and Human Services IRB Guidebook) Interoperability—the ability of two or more systems or components to exchange information and use the information that has been exchanged Investigational device exemption (IDE)—an FDA designation that allows an investigational device to be used in a clinical study to collect safety and effectiveness data supporting a premarket approval application or a pre- market notification submission Investigational new drug application (IND)—a new molecular, antibiotic, or biological drug that is used in a clinical investigation. It also includes biological products used in vivo for diagnostic purposes KRAS—the Kras gene makes the KRAS protein, which is involved in cell signaling pathways, cell growth, and cell death, and may cause cancer when mutated. Agents that block the activity of the mutated Kras gene or its protein may stop the growth of cancer. Large-scale genomic profiling—a strategy that identifies nucleic acid sequences of interest in patient samples Leukemia—cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of blood cells to be produced and enter the bloodstream Levamisole—an antiparasitic drug that is also being studied in cancer therapy with fluorouracil

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM Ligand—a molecule that binds to another molecule (i.e., an antigen that binds to a specific antibody) Lumpectomy—surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it. It is a type of breast-sparing surgery Lymph node negative (node negative)—cancer that has not spread to the lymph nodes Lymphoma—cancer that begins in cells of the immune system Macromolecule—a very large molecule consisting of many smaller struc- tural units, such as nucleic acids, proteins, carbohydrates, or lipids Magnetic resonance imaging (MRI)—a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body that can show the difference between normal and diseased tissue Magnetic resonance spectroscopy—a noninvasive imaging method that provides information about cellular activity (metabolic information). It is used along with MRI, which provides information about the shape and size of the tumor (spatial information). Also called 1H-nuclear magnetic resonance spectroscopic imaging, MRSI, and proton magnetic resonance spectroscopic imaging. Mastectomy—surgery to remove the breast (or as much of the breast tissue as possible) Maximum tolerated dose—the highest dose of a drug or treatment that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found Meduloblastoma—a malignant brain tumor that begins in the lower part of the brain and that can spread to the spine or to other parts of the body. Medulloblastomas are a type of primitive neuroectodermal tumor (PNET) Melanoma—a form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines

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2 GLOSSARy Mercaptopurine—a drug used to treat acute lymphocytic leukemia. It belongs to the family of drugs called antimetabolites. Also called Purinethol Messenger RNA—single-stranded RNA molecule that is complementary to one of the DNA strands of a gene Metabolomics—the systematic study of the unique chemical fingerprints that specific cellular processes leave behind; that is, small-molecule metabolites Metastatic—having to do with metastasis, which is the spread of cancer from the primary site to other places in the body Minimal residual disease—detection of small numbers of leukemia cells that are undetectable by conventional morphologic methods, using assays with greater sensitivity Molecular biology—the branch of biology that deals with the formation, structure, and function of macromolecules essential to life, such as nucleic acids and proteins, and especially with their role in cell replication and the transmission of genetic information Molecular genetic marker—biomarkers that are specific sequences of DNA Molecular profiling—using genomics, proteomics, imaging, and bioinfor- matics to provide a molecular portrait of an individual patients’ disease Morbidity—a disease or the incidence of disease within a population. Mor- bidity also refers to adverse effects caused by a treatment Mortality—refers to the death rate, or the number of deaths in a certain group of people in a certain period of time. Mortality may be reported for people who have a certain disease, live in one area of the country, or who are of a certain gender, age, or ethnic group Multiarm, multistage (MAMS) trial design—a trial design testing a number of new agents (and combinations of agents) simultaneously against a single control arm Multimodality—therapy that combines more than one method of treatment Myelodysplastic syndromes—a group of diseases in which the bone marrow does not make enough healthy blood cells. Also called preleukemia

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20 A NATIONAL CANCER CLINICAL TRIALS SySTEM Myeloma—cancer that arises in plasma cells, a type of white blood cell Nanoparticle—a particle of that is smaller than 100 nanometers (one- billionth of a meter). In medicine, nanoparticles can be used to carry antibodies, drugs, imaging agents, or other substances to certain parts of the body. Nanoparticles are being studied in the detection, diagnosis, and treatment of cancer Nanotechnology—the field of research that deals with the engineering and creation of things from materials that are less than 100 nanometers (one-billionth of a meter) in size, especially single atoms or molecules. Nanotechnology is being studied in the detection, diagnosis, and treatment of cancer Neoadjuvant therapy—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 hor- mone therapy. It is a type of induction therapy Neovacularization—altered blood volume, permeability, perfusion, and vascularity of the tumor tissue Neuroblastoma—cancer that arises in immature nerve cells and affects mostly infants and children Non-Hodgkin’s lymphoma—a large, diverse group of cancers of the immune system cells Non-small cell lung cancer—a group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a micro- scope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer Oncogene—a gene that is a mutated (changed) form of a gene involved in normal cell growth. Oncogenes may cause the growth of cancer cells Oncotype Dx—assay that measures the expression of 21 genes to predict the likelihood of recurrence of ER-positive lymph node-negative breast cancer Ovarian cancer—cancer that forms in the tissues of the ovary; most ovar- ian cancers are either ovarian epithelial carcinomas (cancer that begins in

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21 GLOSSARy the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells) P13k/Akt/mTOR (PAM)—a pathway that regulates several normal cellular functions that are important for tumorigenesis Paclitaxel (Taxol)—an antimitotic drug used to treat several types of cancer by blocking cell growth by stopping cell division Panitumumab (vectibix)—a human monoclonal antibody that is being used to treat colorectal cancer that has spread to other parts of the body and is also being studied in the treatment of other types of cancer. Panitumumab binds to the epidermal growth factor receptor (EGFR) and may block tumor cell growth Peptide—a molecule that contains two or more amino acids (molecules that join together to form proteins) Performance status—a measure of how well a patient is able to perform ordinary tasks and carry out daily activities Personalized medicine—leveraging scientific advances in fields such as genomics, proteomics, molecular biology, and metabolomics to improve the extent to which medical care is personalized to an individual patient and his or her cancer Pharmacodynamics—the study of the biochemical and physiological effects of drugs and the mechanisms of their actions Pharmacogenetics—the study of how a person’s genes affect the way he or she responds to drugs. The goal of pharmacogenetics is to predict what the best drug or the best dose of a drug will be for a person. Also called pharmacogenomics Pharmacology—the study of drug action Phase I trial—a clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed Phase II trial—a clinical trial in which the safety and preliminary efficacy of an intervention are assessed

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22 A NATIONAL CANCER CLINICAL TRIALS SySTEM Phase III trial—a large-scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market Placebo—an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo Positron emission tomography (PET)—a nuclear imaging technique used in medicine in which a small amount of radioactive compound, such as glu- cose (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. Also called positron emission tomography scan Practice guidelines—evidence-based recommendations to guide patient treatment decisions Preclinical study—research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies usually take place before clinical trials in humans are conducted Precompetitive—collaboration among competitors to achieve goals that can- not be feasibly attained alone and have the potential to benefit everyone Predictive biomarker—a biomarker that can identify populations that are likely to be sensitive or resistant to specific treatments Prevalence (disease)—the number of existing cases of a disease in a given population at a specific time Prevention—action taken to decrease the risk of getting a disease or condition Principal investigator—a lead investigator for a research project, such as a clinical trial, who takes direct responsibility for the completion of a funded project Privacy Rule—a federal regulation establishing national standards to pro- tect individuals’ medical records and other health information. The Rule requires appropriate safeguards to protect the privacy of personal health

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2 GLOSSARy information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization Process map—a description of the organizations and decision-making steps involved in a process Prognosis—the likely outcome or course of a disease; the chance of recovery or recurrence Prognostic biomarker—a biomarker that can predict disease progression in the absence of treatment considerations Progression free survival—the length of time during and after treatment in which a patient is living with a disease that does not get worse. Progres- sion-free survival may be used in a clinical study or trial to help find out how well a new treatment works Prospective biomarker-drug codevelopment studies—study designs that simultaneously evaluate the utility of predictive biomarkers and the effect of therapy on outcomes Prospective biomarker validation studies—studies using a prospective design to test the validity of a predictive biomarker for selecting patient therapy Prospective design—in medicine, a study or clinical trial in which partici- pants are identified and then followed forward in time Prostate cancer—cancer that grows in the tissues of the prostate Protected health information—as defined in the Privacy Rule, protected health information is personally identifiable health information created or received by a covered entity Proteomics—the study of the structure and function of proteins, including the way they work and interact with each other inside cells Protocol—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

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM Radiation therapy—the use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors Radionuclide—an unstable form of a chemical element that releases radia- tion as it breaks down and becomes more stable. Radionuclides may occur in nature or be made in a laboratory. In medicine, they are used in imaging tests and in treatment Radiopeptide—a compound consisting of two or more amino acids (the building blocks of proteins) that has been joined with a radioactive sub- stance for use in biomedical imaging and/or therapy Raloxifene—a selective estrogen receptor modulator drug used to reduce the risk of invasive breast cancer in postmenopausal women who are at high risk of the disease or who have osteoporosis. It is also being studied in the prevention of breast cancer in certain premenopausal women and in the prevention and treatment of other conditions. Raloxifene blocks the effects of the hormone estrogen in the breast and increases the amount of calcium in bone Randomized controlled trial (RCT)—a study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best Randomized distribution trial design—a trial design that enriches the patient population with likely responders RECIST (Response Evaluation Criteria in Solid Tumors) guidelines—a stan- dard set of criteria to assess treatment response via biomedical imaging Recurrence—cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body Remission—a decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body

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2 GLOSSARy Repository—see Biorepository Retrospective analysis—a study design that starts with the present condition of a population of individuals and collects data about their past history Rhabdomyosarcoma—cancer that forms in the soft tissues in a type of muscle called striated muscle. Rhabdomyosarcoma can occur anywhere in the body Routine care—care that would be received by a patient undergoing stan- dard treatment, and would include such items as room and board for patients who are hospitalized, diagnostic and laboratory tests and moni- toring appropriate to the patient’s condition, post-surgical care when indi- cated, office visits, and so on Screening—checking for disease when there are no symptoms Selection bias—this phenomenon occurs when data are more likely to be collected from one subset of the population than from a representative sample of the entire population. This can cause systematic differences between the characteristics of the individuals included in a study and the individuals not included Signal transduction—the process by which a cell responds to substances in its environment. The binding of a substance to a molecule on the surface of a cell causes signals to be passed from one molecule to another inside the cell. These signals can affect many functions of the cell, including cell division and cell death. Cells that have permanent changes in signal trans- duction molecules may develop into cancer Single photon emission computed tomography (SPECT)—a special type of computed tomography (CT) scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. SPECT can give information about blood flow to tissues and chemical reactions (metabolism) in the body Sorafenib (nexavar)—a kinase inhibitor that stops cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. Sorafenib is used to treat advanced kidney cancer and a type of liver cancer that cannot be removed by surgery

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM Standard of care—in medicine, treatment that experts agree is appropriate, accepted, and widely used. Also called best practice and standard therapy Standard operating procedures (SOPs)—instructions detailing steps and activities of a process or procedure Tamoxifen—a drug that interferes with the activity of estrogen, a female hormone, and used to treat breast cancer Targeted therapy—a type of treatment that uses drugs or other substances (such as monoclonal antibodies) to identify and attack cancer cells without harming normal cells. Targeted therapy may be less harmful to normal cells than other types of cancer treatments Thalidomide—an angiogenesis inhibitor drug that is used to treat multiple myeloma in patients who have just been diagnosed Thoracic—having to do with the chest Time to progression—a measure of time after a disease is diagnosed (or treated) until the disease starts to get worse Toxicity—the extent to which something is poisonous or harmful Translational research—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 Trastuzumab—a monoclonal antibody that binds to HER-2 (human epi- dermal growth factor receptor 2), and can kill HER-2-positive cancer cells. Used to treat breast cancer that is HER-2 positive Trial concept—an initial idea for a clinical trial Tumor response—a change in tumor size, usually defined as tumor shrink- age by 50 percent bidimensionally or 30 percent unidimensionally Type I error—also known as a “false positive,” occurs when a difference is observed when in truth there is none Type II error—also known as a “false negative,” the error of failing to observe a difference when in truth there is one

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2 GLOSSARy Tyrosine kinase inhibitor—a drug that interferes with cell communication and growth and may prevent tumor growth ultrasound—a procedure in which high-energy sound waves are bounced off internal tissues or organs and make echoes. The echo patterns are shown on the screen of an ultrasound machine, forming a picture of body tissues vincristine (oncovin) sulfate—a drug used to treat acute leukemia that blocks cell growth by stopping cell division Wilms’ tumor—a disease in which malignant cells are found in the kidney, and may spread to the lungs, liver, or nearby lymph nodes. Wilms tumor usually occurs in children younger than 5 years old

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