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You are here: Home / Protocols / EDRN Breast and Ovary Cancer CVC, Study 4: Phase 3 Validation of Ovarian Cancer Serum Markers in Preclinical WHI Samples

EDRN Breast and Ovary Cancer CVC, Study 4: Phase 3 Validation of Ovarian Cancer Serum Markers in Preclinical WHI Samples

374

No coordinating investigator defined.

No involved investigator sites defined.

CA125, HE4, MSLN, MMP7
Proteomics
Other, Specify
Breast and Gynecologic Cancers Research
3

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

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.


New Funding Opportunity: Biomarker Development Laboratories for the Early Detection Network: Applications Due May 23

Update: Pre-application webinar information now available.

The National Cancer Institute's Division of Cancer Prevention has released a new funding opportunity to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers.

The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this funding opportunity) should be focused on one or more of the following cancers: breast, prostate and other genitourinary organs, or lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.

The newly funded units of the Early Detection Research Network will be announced later in April. Successful applicants have already been notified. Those researchers who were not successful during the last round of applications are encouraged to apply to this opportunity.