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Old 02-17-2014, 12:28 PM   #1
'lizbeth
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Post Understanding the language of clinical trials

The language of Clinical Trials is sometimes difficult to understand. While the words and phrases are in English, they often have specific meanings derived from the disciplines of statistics and bio-statistics, and include medical terms with Greek or Latin roots. These meanings may be unfamiliar to patients and family members. This glossary is intended to assist patients in understanding clinical trials generally, but it does not include language that may be specific to trials for a particular disease.

Underlined words found in any definition are included in this glossary.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

ECOG Performance Status Scale and Karnofsky Status Scale Comparison
The Staging of Cancer A
Accrual – 1. Process of enrolling patients in a trial. 2. Number of patients enrolled, or planned for enrollment in a trial.

Adjuvant – Treatment secondary to the primary treatment. Eg: Chemotherapy after surgery is adjuvant treatment. A. treatment is usually prescribed in hope of preventing recurrence or further spread of disease. Cf: Neo-Adjuvant.

Arm – One of the treatment groups of a randomized trial. The majority of randomized trials have 2 a., but some may have more.

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B
Best Supportive Care – Treatment to control, prevent and relieve complications and side effects and to improve comfort and quality of life.

Blind – Aspect of randomized trial in which the patient is not told the arm of the trial to which he is assigned.

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C
Clinical – 1. Reference to the treatment of humans, rather than animals or laboratory studies. 2. General use of a treatment by a physician.

Cohort – A group of patients within the same arm of a trial.

Complete Response (CR) – Condition post treatment in which no trace of detectable disease remains. Does not equate to "cure," though some patients with a c.r. may be "cured."

Control – The arm of a randomized trial in which participants receive the standard treatment or a placebo.

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D
Disease Free Survival (DFS) – Length of time post treatment, the patient survives without evidence of detectable disease. Cf: Progression Free Survival.

Dose Limiting Toxicity (DLT) – Appearance of side effects during treatment that are severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.

Double Blind –
Aspect of a randomized trial in which neither the participant nor the investigator knows the arm of the trial to which the patient is assigned. Purpose is to eliminate any bias in reporting of results.

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E
ECOG Status – Scale for measuring performance status, developed by the Eastern Cooperative Oncology Group. Many trials require ECOG s. of "0" or "1," and trials enrolling patients with status of "3" are rare. See Karnofsky Status and also see Appendix 1.

End Point –
The goal of a trial: i.e. what the trial is attempting to find out. Clinical trials must clearly define the e.p. at the outset. E.p. often includes response rate, survival and toxicity.

Evaluable Disease – One or more tumors which are known to be present, but which cannot be measured. eg: Bony lesions, pleural effusion, ascities. Cf: Measurable disease.

Exclusion Criteria – Factors which will prevent enrollment in a trial. Commonly, age, performance status, medical history. Cf: Inclusion criteria.

Experimental – The arm of a randomized trial in which patients receive the investigational therapy. Cf: Control.


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Food and Drug Administration (FDA) – United States government agency with jurisdiction over manufacture and testing of drug products. All Clinical Trials must have FDA approval before enrolling patients.

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G
Grade – 1. In clinical trials, a numeric scale used to rate the severity of toxicity associated with a treatment. Each side effect is separately rated from "0" to "4." "0" = side effect not present. "1"= present but minor. "2"=present, moderate effect. "3"= present, with significant effect. "4" = potentially life threatening effect. G. "3" or "4" toxicity usually results in further treatment being delayed or stopped. If resumed, treatment may be at lower dosage or frequency. 2. Scale used to refer to the levels of abnormality and aggressiveness of a disease.

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H
Histologic Confirmation – Laboratory examination of tissue from biopsy or surgical procedure to determine the presence of disease and disease type. Many trials require histologic confirmation of disease as a condition of enrollment.

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I
In vitreo – Latin. Literally "in glass." Refers to laboratory testing of a drug or combination of drugs.

In vitro – Latin. Out of the body. Another description of laboratory testing.

In vivo – Latin. Literally "in life." Refers to laboratory testing of therapy on animals (often mice or rats) in laboratory. 2. Testing on humans in a clinical setting.

Inclusion Criteria – Factors which must be present in order for patient to enroll in a trial.
Commonly included are age, performance status, measurable disease, and aspects of medical and treatment history. For scientific validity all criteria must be met for enrollment in a trial.

Informed Consent – Process of informing a patient about the potential risks and benefits of participation in a trial. No patient may be enrolled in a trial without his i.c. The process includes discussion with the physician-investigator and also with a research nurse or coordinator. If the patient agrees to participate, an i.c. document outlining in plain language what treatment the trial is testing, the risks and benefits of participation, and the alternatives to participation, is signed by the patient and is witnessed by a disinterested person.

Institutional Review Board (IRB) – A review panel which approves trials prior to initiation to assure conformity with ethical and scientific standards, and that the Informed Consent is adequate. At UCLA, there are 2 such Boards: The Human Subjects Protection Committee (HSPC) and the Institutional Scientific Peer Review Committee (ISPRC), and both must approve a trial prior to the enrollment of participants.

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K
Karnovsky Status – A performance status scale which rates the severity of symptoms and degree of disability on a scale from 100% (no symptoms) to 0% (deceased). See ECOG Status, see also Appendix 1.

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L
Lesion – 1. Pathologic tissue change. 2. An individual site or point in a multifocal disease.

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M
Maximum Tolerated Dose (MTD) – Highest dosage of a drug, drug combination or other treatment modality that patients can safely tolerate. Usually determined by Phase I Trial.

Measurable Disease – Tumor or tumors which can be clearly measured for size. Eg: lung nodules that can be clearly separated from other tissue in radiologic studies, or lumps which can be felt or seen by the naked eye and measured. A requirement of many Phase II Trials, so that any response can be measured.

Metastasis – 1. "Secondary" tumor at a location remote from original, "primary" tumor site. Cancer cells may "migrate" from the original site to another organ, and multiply at the second site, forming a new tumor. 2. Process by which such secondary tumors form. Plural: metastases. Adjective: metastatic.

Multicenter – A trial enrolling patients at several locations ("sites") simultaneously.

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N
Neo-Adjuvant – Initial treatment which is not the primary therapy. Eg: Chemotherapy or radiation prior to surgery. Often administered in instances of locally advanced disease in the hope that the size of the tumor is reduced in order that it might be completely excised by another therapy, or permit less radical treatment than otherwise might be required. Cf: Adjuvant.

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O
Open Label – Type of trial in which both the investigator and the participant know which drug or combination of drugs the patient is receiving.
Many Phase III Trials are open label.

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P
Partial Response – A post treatment decrsease in the size of a measurable tumor of at least 50%, but less than 100% of the total cros section.

Performance Status – 1. A measure of the level of activity of which a patient is capable. 2. By implication, a measure of the severity of disease. See ECOG Status and Karnofsky Status.

Phase I Trial – Trial to determine the safety of a therapy or combination therapy not previously used in treating humans. Cf: in vitreo, in vitro, in vivo. Phase I trials typically enroll patients in cohorts, with each successive cohort receiving an increasing dose of the investigational therapy until dose limiting toxicity (DLT) is observed in a defined number of patients. The dosage level below the level of DLT is then defined as the maximum tolerated dose (MTD). Patients enrolled in Phase I trials have disease which is refractory to standard therapies, and usually only evaluable disease is required.

Phase II Trial – Trial to determine the effectiveness of a therapy or combination therapy. Patients in a Phase II Trial usually are those with refractory disease, and must have measurable disease so that the response to the investigational treatment can be evaluated. Phase II trials of the same therapy are often conducted on several different types of disease to determine if the therapy is effective for more than a single type of cancer.

Phase III Trial – Trial to compare 2 or more treatments for a single type and stage of disease. The end point of a Phase III Trial is usually survival or disease free survival. Phase III trials are most often randomized. Some Phase III trials compare the investigational therapy (the experimental arm) with the current standard of care or best supportive care (the control arm). Other Phase III trials compare 2 existing treatments for the same disease.

Placebo –
Inert substance (eg: sugar pill) used as "therapy" for 1 arm of a randomized trial, most often a double blind trial. Often in a trial to compare two different treatments, patients will be given both a placebo with the appearance of one therapy and an actual dose of the other of the therapies.

Progressive Disease – Term applied when disease is worsening, documented by tests showing that the tumor is growing or than additional tumors have appeared. Some trials are limited to patients with progressive disease so that if improvement occurs it can be assumed to be the result of the investigational therapy.

Progression Free Survival – Time during which the patient lives without any worsening of the disease.

Protocol –
1. Detailed plan of treatment including dose and schedule of any drug or other therapy used. 2. Sometimes used as a synonym for "Clinical Trial."

Protocol Document – Written document which describes in detail the plan for conduct of a clinical trial, including history of pre-clinical studies, detailed description of how therapy will be administered, inclusion and exclusion criteria, criteria for delaying or stopping treatment, and a schedule of tests to be performed prior to, during, and following treatment. Also includes the informed consent document.

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Q
Quality of Life – 1. Overall enjoyment of life and activities of daily living. 2. Measure of the ability to perform customary tasks and sense of well-being. Many trials include a q.o.l. survey, often including a patient diary.

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R
Randomized Trial – Clinical trial having at least 2 arms. The decision as to which arm the patient is assigned is made by chance, usually by a computer program.

Refractory –
Disease which is not responsive to standard treatment. Refractory is applied to a patient’s disease only after a patient’s disease has failed to respond to a standard treatment, or if the patient cannot tolerate a standard treatment.

Response – Decrease in the size of a tumor, post therapy. See Complete Response and Partial Response.

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S
Stage – Measure of how far the disease has advanced in terms of size of the primary tumor, lymph node involvement and spread (metastasis) to other sites in the body. Each cancer type has its own staging system. See Appendix 2.

Standard of Care – Generally accepted treatment for a disease or condition. Treatment which is not experimental and which has FDA
approval.

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T
TLA – Three Letter Acronym. Eg: DLT, MTD.

Toxicity – Literally, the state of being poisonous. In Clinical Trials, t. is a reference to side effects of the therapy.

Tumor – A lump, swelling, or mass. A t. may be benign or malignant. Synonym: Neoplasm.

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U
Upper Limit of Normal (ULN) – Frequently used in setting inclusion criteria for participation in a trial. Describes how far above the normal limit for a given test the patient may be, and still qualify for inclusion in the trial. Eg: "Bilirubin < 2 x ULN," which translates as "bilirubin less than twice the upper limit of normal." (Bilirubin is a substance in the blood, and elevated bilirubin is often an indicator of liver problems.)

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W
World Health Organization (WHO) Status – A performance status measure very similar to ECOG status.

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Old 02-18-2014, 03:49 AM   #2
Aussie Girl
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Re: Understanding the language of clinical trials

Great post, 'Lizbeth!

AG
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31mm Infiltrating duct carcinoma
Grade 3, ER/PR-, HER2+, Neg Sentinel nodes x 5
49mm field of DCIS
17 June '13: Screen detected impalpable mass, Mammogram neg, US.
25 June '13: Diagnosed after multiple biopsies and MRIs
28 June '13: Left lumpectomey
4 July '13: Left Mastectomy
12 August '13: Commenced TCH chemo
Mid December '13 : TCH finished. Herceptin continuing three weekly.
4 August 2014- Herceptin infusions finished.
END OF THERAPY - YAY!
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