EDRN Breast and Ovary Cancer CVC, Study 4: Phase 3 Validation of Ovarian Cancer Serum Markers in Preclinical WHI Samples
- Abbreviated Name
- CVC Study 4
- Lead Investigator
- Li, Christopher — Fred Hutchinson Cancer Center
- Coordinating Investigator
- No coordinating investigator
- Involved Investigators
The WHI offers an opportunity to evaluate ovarian cancer markers and screening decision rules developed and validated in EDRN CVC Studies 2 and 3 in women who were not being screened. It is particularly well suited to validation of risk markers, since many serum samples were drawn well before clinical diagnosis of cancer in the WHI cohorts. A strategy is needed to identify from among the general population of women over the age of 50 those at high-risk for a diagnosis of ovarian/fallopian tube cancer so that they can be referred for appropriate surveillance, imaging or surgical consult. Tools to identify high-risk women will be investigated including serum markers CA125, HE4, MSLN, and MMP7 and epidemiologic risk factors. We will optimize decision rules using stored serum samples from the WHI OS and conduct a simulated prospective validation using stored serum samples from the WHI CT. Decision rules to select women for ovarian cancer screening will be investigated as well as decision rules for use in ovarian cancer screening.
To optimize and validate ovarian cancer screening decision rules using serum markers, and evaluate the contribution of epidemiologic risk factors to these rules: 1. Identify the best assays for use in measuring HE4, MSLN, MMP7 and SLPI by evaluating candidate assays in clinical samples and in preclinical samples available from the CARET repository. 2. Using 240 cases and 480 matched controls from the WHI OS we will define and optimize decision rules. 3. Using approximately 160 cases and 640 matched controls from the WHI CT we will test the decision rules developed in Aim 2.
ROC curves; logistic regression
- No publications available at this time for this protocol.
- No biomarkers available at this time for this protocol.
- No data collections available at this time for this protocol.
- Start Date
- Aug 1 2011
- Estimated Finish Date
- Sep 21 2014
- Protocol ID
- Protocol Type
- Field of Research
- Collaborative Group
- Breast and Gynecologic Cancers Research Group
- Cancer Types
- (No cancer types specified)
- Phased Status