CA-125 in Screening Patients at High Risk for Ovarian Cancer
Recruitment status was Active, not recruiting
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.
Other: physiologic testing
Procedure: study of high risk factors
|Study Design:||Primary Purpose: Screening|
|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 Start Date:||June 2003|
- 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).
- 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.
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|Principal Investigator:||Edward E. Partridge, MD||University of Alabama at Birmingham|