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
Abstact
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.
Outcome
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%.
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
- Field of Research
- UNKNOWN
- Collaborative Group
- Breast and Gynecologic Cancers Research Group
- Cancer Types
-
- Malignant neoplasm of ovary