Ovarian Cancer Clinical Trial
Official title:
Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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