Spots Global Cancer Trial Database for CA-125 in Screening Patients at High Risk for Ovarian Cancer

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Trial Identification

Brief Title: CA-125 in Screening Patients at High Risk for Ovarian Cancer

Official Title: Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

Study ID: NCT00080639

Conditions

Ovarian Cancer

Interventions

physiologic testing

study of high risk factors

Study Description

Brief Summary: RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment. PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.

Detailed Description: OBJECTIVES: Primary * Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. * Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy). Secondary * Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients. OUTLINE: This is a multicenter, pilot study. Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results. Patients are followed at 6 months and then annually thereafter. PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.