EDRN Breast and Ovary Cancer CVC, Study 3: Phase 3 Validation of screening decision rules in preclinical UKCTOCS serial samples

Abbreviated Name
CVC Study 3
Lead Investigator
Li, ChristopherFred Hutchinson Cancer Center
Coordinating Investigator
No coordinating investigator
Involved Investigators


We will collaborate with investigators from University College London to test a screening decision rule in preclinical serial samples from the U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) to learn if the panel can do better than CA125 alone. The UKCTOCS is an ideal setting for retrospective validation of an early detection marker panel and decision rule because it offers serial samples collected annually and use of imaging in women with rising CA125. Multi-modal strategies using serum markers HE4, MSLN, MMP7, and CA125 will be compared to strategies relying exclusively on CA125 and transvaginal sonography (TVS).


1.   Using PLCO preclinical serial samples, we will optimize a serum marker decision rule using CA125, HE4, MSLN, & MMP7 to select women for surgical consult, additional testing, or early recall. 2.   Using UKCTOCS preclinical samples, we will validate the serum marker decision rule developed in Aim 1 using CA125, HE4, MSLN, & MMP7 to select women for surgical consult or additional testing. 3.   Using UKCTOCS preclinical samples we will validate HE4 as a second-line screen in a screening strategy that uses rising CA125 to select women for additional testing.

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
Nov 1 2012
Estimated Finish Date
May 31 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