EDRN Breast and Ovary Cancer CVC, Study 2: Phase 3 retrospective validation of ovarian cancer early detection markers in serial preclinical samples from the PLCO trial

Abbreviated Name
CVC Study 2
Lead Investigator
Li, ChristopherFred Hutchinson Cancer Center
Coordinating Investigator
No coordinating investigator
Involved Investigators


Over 70% of women with ovarian/fallopian tube cancer (OC) are diagnosed with advanced stage disease which has a 5-year relative survival rate of 30%. Five-year survival is 90% when disease is confined to the ovaries, but overall survival is poor because only 25% of cases are found early. Screening for ovarian cancer using tools with high sensitivity is potentially cost-effective, but because OC is so rare, very high specificity is needed to achieve an acceptable PPV. We have conducted preliminary work both in clinical and in preclinical (CARET) samples. We have identified candidate markers, developed assays for novel markers including HE4 and MSLN, and evaluated their diagnostic performance. We evaluated the markers’ contribution to a diagnostic panel in a standard set in order to identify the best of the candidates and developed methods for combining markers to define a decision rule for a marker panel. We found that our PEB rule yields comparable performance to the Single Threshold (ST) rule 2 years earlier, using the same two markers. The PEB makes an even larger contribution with the 4-marker panel. The 4-marker panel with the PEB rule represents a substantial improvement over any of the other decision rules as a first-line screen to select women for imaging. Our goal in the proposed work is to estimate the improvement in performance possible in the PLCO serial samples.


1.   To validate and refine 2-marker and 4-marker algorithms. 2. In a separate independent validation set (the blinded half of the PLCO serial samples) we will validate the refined 2-marker and 4-marker algorithms.

Analytic Method

ROC curves; logistic regression


  • No publications available at this time for this protocol.


  • No biomarkers available at this time for this protocol.

Data Collections

  • No data collections available at this time for this protocol.
Start Date
Oct 25 2011
Estimated Finish Date
Jun 30 2014
Protocol ID
Protocol Type
Field of Research
Collaborative Group
Breast and Gynecologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of ovary
Phased Status

Associated Forms