Ovarian Cancer Screening Pilot Trial In High Risk Women

Abbreviated Name
Ovarian Cancer Screening Pilot Trial In High Risk Women
Lead Investigator
Lynch, Henry — Creighton University
Coordinating Investigator
No coordinating investigator
Involved Investigators

Abstract

BACKGROUND: No proven ovarian cancer (OC) screening strategy exists for women who are at increased risk for the disease. A risk of ovarian cancer algorithm (ROCA) using serial CA125 values have previously shown greater positive predictive value (PPV) and sensitivity than a single CA125 in screening women at general population risk. We hypothesized that using ROCA would yield a reasonable PPV for ovarian cancer screening in a cohort at increased risk. METHODS: Between 7/2001 and 9/2006, 25 sites (14 CGN, 3 ovarian SPOREs, 1 EDRN, 7 others) prospectively enrolled patients. Inclusion criteria included: among self, 1st degree and 2nd degree relatives in same lineage either (i) BRCA 1/2 mutation, or (ii) two of OC or early onset (age < or = 50) breast cancer (BC), or (iii) Ashkenazi ethnicity and 1 of OC or BC. A previous diagnosis of OC excluded subjects. Subjects underwent CA125 every 3 months and the risk of having ovarian cancer based on the CA125 profile was recalculated after each test. ROCA referred subjects with risk > 1% to ultrasound (US) and risk > 10% additionally to a gynecologic oncologist. Objectives included PPV for study indicated surgery, sensitivity, and compliance. Sample size was chosen to observe 8 OC endpoints with a power of 80% to rule out PPV < or = 10% if the true PPV = 20%.

Aims

To bring EDRN participation into the CGN study of early detection of ovarian cancer in high risk women using serum and plasma markers. This is a project with Stephen Skates, Ph.D. (Massachusetts General Hospital, MGH Biostatistics Center) “Ovarian cancer screening pilot trial in high risk women”. We will recruit 30 women for this trial.

Analytic Method

No analytic method available.

Comments

No comments available.

Outcome

2,343 high risk women enrolled, with 6,284 women years of screening and 19,549 CA125s obtained. There were 628 (10%/yr)referrals to ultrasound (US) with 414 US performed. 38 women underwent study indicated surgeries. 9 OCs were identified during screening, 3 were prevalent (1 early, 2 late stage),and 6 were incident (5/6 = 83% early, 1 late). 3 of the 6 incident cases were found on prophylctic oophorectomy in early stage. ROCA deteted 2 in early stage of remaining 3 incident cases, and 3 of 3 prevalent cases. The PPV was 5/38 = 13% (95% CI 4.4%, 28%) and sensitivity was 5/6 = 83%, CI (36%, 99%). There was high compliance with CA125 testing throughout the study, with 84%, 85%, 85%, 82% subjects returning within 1 month of schedule for 4 tests. CONCLUSION: Frequent CA125 testing using ROCA results in an acceptable PPV and high compliance in a cohort of women at increased risk for OC. A definitive screening study (> or = 30 incident cases) using ROCA with serial CA125 and possibly additional markers is required to define sensitivity for early stage OC.

Secure Outcome

No secure outcome available.

Publications

  • No publications available at this time for this protocol.

Biomarkers

  • No biomarkers available at this time for this protocol.

Data Collections

  • No data collections available at this time for this protocol.
 Team Project
Finish Date
May 26 2008
Protocol ID
83
Protocol Type
Collaboration
Fields of Research
  • UNKNOWN
Collaborative Group
Breast and Gynecologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of ovary

Associated Forms