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CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

2014-08-27 03:55:21 | BioPortfolio

Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known if ultrasound is more effective with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.

PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.

Description

OBJECTIVES:

- Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women.

- Determine the physical morbidity of ovarian cancer screening in this population.

- Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population.

- Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population.

- Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies.

- Compare the performance of these screening strategies in this population.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.

- Arm I: Participants do not undergo screening.

- Arm II: Participants undergo screening with an annual CA 125 level. Depending on the results of the test, some patients may undergo additional screening.

- Arm III: Participants undergo screening with an annual transvaginal or transabdominal ultrasound. Depending on the results of the test, some patients may undergo additional screening.

Participants in all arms complete a health questionnaire at 3.5 and 7 years after study entry.

PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 3 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Screening

Conditions

Ovarian Cancer

Intervention

screening questionnaire administration, annual screening

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:21-0400

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Medical and Biotech [MESH] Definitions

The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

Testing or screening required by federal, state, or local law or other agencies for the diagnosis of specified conditions. It is usually limited to specific populations such as categories of health care providers, members of the military, and prisoners or to specific situations such as premarital examinations or donor screening.

Examination of urine by chemical, physical, or microscopic means. Routine urinalysis usually includes performing chemical screening tests, determining specific gravity, observing any unusual color or odor, screening for bacteriuria, and examining the sediment microscopically.

Measures for assessing the results of diagnostic and screening tests. Sensitivity represents the proportion of truly diseased persons in a screened population who are identified as being diseased by the test. It is a measure of the probability of correctly diagnosing a condition. Specificity is the proportion of truly nondiseased persons who are so identified by the screening test. It is a measure of the probability of correctly identifying a nondiseased person. (From Last, Dictionary of Epidemiology, 2d ed)

In vivo method of screening investigative anticancer drugs and biologic response modifiers for individual cancer patients. Fresh tumor tissue is implanted under the kidney capsule of immunocompetent mice or rats; gross and histological assessments follow several days after tumor treatment in situ.

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