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arterial embolization n.
Blocking of an artery by a clot of foreign material. This can be done as treatment to block the flow of blood to a tumor.
asbestos n.
Any of several minerals that readily separate into long flexible fibers. Formerly used as fireproof insulating materials, asbestos has been implicated as causes of certain cancers.
bowel n.
A section or part of the intestines, especially the part of the intestine that connects to the anus
cadmium n.
Metallic element used especially in protective platings and in bearing metals
chemotherapy n.
Use of chemical agents in the treatment or control of disease or mental illness
clinical trial n.
Study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.
Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
colon n.
The part of the large intestine that extends from the small intestine to the rectum. It is approximately 5 feet long in adults and is responsible for forming, storing and expelling waste matter.
computed tomography (CT) scan n.
An X-ray procedure in which the X-ray beam moves around the body, taking pictures from different angles. These images are combined by a computer to produce a detailed cross-sectional picture of the inside of the body.
control n.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while another group (the control) is given either a standard treatment for the illness or a placebo.
dialysis n.
Mechanical process that partly performs the work that healthy kidneys normally do. The main functions of dialysis include clearing wastes from the blood; restoring proper balance of certain electrolytes in the blood; and eliminating extra fluid from the body. For people with end-stage renal disease, dialysis is the only way to prolong life, other than receiving a kidney transplant.
exclusion criteria n.
When determining a patient’s eligibility for a clinical trial, exclusion criteria describe those factors that, if present, would disallow a candidate’s participation in the study. Common exclusion criteria include other serious diseases, pregnancy and compromised immunity.
fast track n., adj.
Designation that the US Food and Drug Administration (FDA) reserves
for products intended to treat a serious or life-threatening condition,
and that have the potential to address an unmet medical need.
As a fast track product, the FDA will take appropriate actions
to expedite the development and review of the investigational
product’s approval application.
hormonal therapy n.
Treatment of cancer by alteration of the hormonal balance. Some cancer will only grow in the presence of certain hormones.
hormone n.
Naturally occurring substance secreted by specialized cells that affects the metabolism or behavior of other cells possessing functional receptors for the hormone
immune system n.
The body system, made up of many organs and cells, that defends the body against infection, disease and foreign substances. The term describes the interacting combination of all the body’s ways of recognizing cells, tissues, objects and organisms that are not part of itself, and initiating the immune response to fight them
immunotherapy n.
Treatment of disease by stimulating the immune system. Also called immune therapy, biological therapy, or biological response modifier therapy.
inclusion criteria n.
When determining a patient’s eligibility for a clinical trial, inclusion criteria describe those factors that must be present in order for a candidate to participate in the study.
informed consent n.
A process in which a person learns key facts about a clinical trial, including potential risks and benefits, before deciding whether or not to participate in a study. Informed consent continues throughout the trial.
Institutional Review Board (IRB) n.
Group of scientists, doctors, clergy and consumers at each health care facility that participates in a clinical trial. IRBs are designed to protect study participants. They review and must approve the action plan for every clinical trial. They check to see that the trial is well designed, does not involve undue risks, and includes safeguards for patients.
interferon n.
Any of a family of glycoproteins derived from human cells that normally has a role in fighting viral infections by preventing virus multiplication in cells
interleukin n.
Any of several secreted regulatory proteins that are members of the family of cytokines (immune system chemicals) that affect functions of specific cell types. Interleukins are produced by immune system cells such as lymphocytes and macrophages and monocytes, and modulate inflammation and immunity by regulating growth, mobility and differentiation of lymphoid and other cells.
intravenous (IV) adj.
Used in administering fluids or medicines into the veins
liver n.
Large, vascular glandular organ of vertebrates that secretes bile (a fluid that aids in the breakdown and absorption of fats). In addition, the liver also modifies many substances in the blood. For example, it forms urea, the chief solid component of mammalian urine. The liver also converts sugars into a storage form called glycogen, which the liver then stores until it is needed for energy.
lymph node n.
Any of the small, bean-shaped organs located throughout the lymphatic system. The lymph nodes contain the immune system cells lymphocytes, which can trap cancer cells or bacteria that are traveling through the body in lymph.
metastasis n.
Transfer of disease from one organ or part to another not directly connected with it. It may be due either to the transfer of pathogenic microorganisms (for example, tubercle bacilli) or to transfer of cells, as in malignant tumors. The capacity to metastasize is a characteristic of all malignant tumors.
nephrectomy n.
The surgical removal of a kidney
outpatient n.
A patient who receives treatment at a hospital without staying overnight
pancreas n.
Large lobed gland that secretes the hormones insulin and glucagon (both of which regulate blood sugar levels) in addition to enzymes involved in the digestion of fats and proteins in the small intestine
Phase 1, Phase 2, Phase 3 n., adj.
Phase 1 trial
The first step in testing a new treatment in humans. These studies test the
best way to give a new treatment (for example, by mouth, intravenous
infusion, or injection) and the best dose. The dose is usually
increased a little at a time in order to find the highest dose
that does not cause harmful side effects. Because little is known
about the possible risks and benefits of the treatments being
tested, Phase 1 trials usually include only a small number of
study volunteers.
Phase 2 trial
In cancer studies, a Phase 2 trial is a study to test whether a new treatment
has an anticancer effect (for example, whether it shrinks a tumor
or improves blood test results) and whether it works against a
certain type of cancer.
Phase 3 trial
A study to compare the results of people taking a new treatment with the results
of people taking the standard treatment (for example, which group
has better survival rates or fewer side effects). Phase 3 trials
may include hundreds of people and are designed to prove the safety
and efficacy of a new treatment.
placebo n.
Inactive substance that has no treatment value
protocol n.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment
radiation therapy n.
Treatment of disease using high energy radiation such as X-rays
randomized adj.
Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. In a randomized clinical trial, 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.
recur v.
To happen or appear once again or repeatedly
remission n.
Complete or partial disappearance of the signs and symptoms of disease in response to treatment. The period during which a disease is under control. A remission is not necessarily a cure.
renal cell carcinoma n.
Also known as renal cell cancer. Renal cell carcinoma is the most common type of kidney cancer, accounting for about 85 percent of all cases.
side effect n.
Problem that occurs when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
stage n.
The extent to which cancer has spread from its original site to other parts of the body. Stage is usually denoted by a number from stage I (least severe) to stage IV (more advanced).
standard of care n.
A currently accepted and widely used treatment for a certain disease, based on the results of past research. Also called standard therapy.
tuberous sclerosis n.
Rare, multisystem genetic disease that causes benign tumors to grow in the brain and on other vital organs such as the kidneys, heart, eyes, lungs and skin. It commonly affects the central nervous system and results in a combination of symptoms, including seizures, developmental delay, behavioral problems, skin abnormalities and kidney disease. Also called tuberous sclerosis complex (TSC).
tumor n.
Abnormal uncontrolled growth or mass of body cells, which may be malignant or benign, and has no physiological function
urine n.
Yellowish liquid containing waste products that is excreted by the kidneys and discharged through the urethra
US Food and Drug Administration (FDA) n.
The branch of the US Department of Health and Human Services charged
with ensuring the safety and effectiveness of new drugs before
they can go on the market. The FDA relies on the results of clinical
trials that provide reliable information about a treatment’s
effects on humans to decided whether or not new drugs should be
approved.
When considering a new drug, the FDA faces two challenges: first, making sure that the drug is safe and effective before it is made widely available; and second, ensuring that drugs that show promise are made available as quickly as possible to the people they might help. To deal with these challenges, the FDA maintains a rigorous review process.
vaccine n.
Preparation containing immune-stimulating agents that is administered to trigger an immune response against a specific disease or infection
X-ray n.
High-energy electromagnetic radiation. It has a wavelength between 0.01 and 10 nanometers, which is between gamma rays and ultraviolet light, and can penetrate solids and ionize gas.
Also, a type of irradiation used for imaging and diagnostic purposes that uses energy beams of very short wavelengths to generate images on photographic film. Dense parts of the body, such as bones, absorb the X-rays and consequently appear as lighter regions on the developed film. It is the most common form of imaging technique used in clinical practice worldwide.
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