Abbreviated Name

CVC Study 3

Lead Investigator

Li, Christopher — Fred Hutchinson Cancer Center

Coordinating Investigator

No coordinating investigator

Involved Investigators

• Li, Christopher — Fred Hutchinson Cancer Center
• Urban, Nicole — Fred Hutchinson Cancer Center

Abstract

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).

Aims

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

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.

Start Date

Nov 1 2012

Estimated Finish Date

May 31 2014

Protocol ID

373

Protocol Type

Validation

Fields of Research

• Proteomics

Collaborative Group

Breast and Gynecologic Cancers Research Group

Cancer Types

• Malignant neoplasm of ovary

Phased Status

3