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Validation of a Risk Assessment Decision Rule for Epithelial Ovarian Cancer

Principal Investigator
Name
Nicole Urban
Degrees
PhD
Institution
Fred Hutchinson Cancer Research Center
Position Title
Research Professor
Email
About this CDAS Project
Study
PLCO (Learn more about this study)
Project ID
PLCO-6
Initial CDAS Request Approval
Dec 3, 2012
Title
Validation of a Risk Assessment Decision Rule for Epithelial Ovarian Cancer
Summary
Currently, risk reduction surgery to prevent ovarian cancer is reserved for BRCA mutation carriers, but it is likely to be recommended for a more broadly defined group of women in the future based on recent advances in our understanding of the disease process. We have a unique opportunity to use data from the Womens Health Initiative (WHI) Observational Study (OS), the WHI Clinical Trial (CT) and the Prostate, Lung, Colon and Ovary (PLCO) trial to develop and validate a risk-assessment tool to identify women for whom surgical prevention may be warranted. The tool is innovative in its use of serum markers as well as epidemiologic risk factors, facilitating intervention early in the disease process to maximize clinical impact.
Aims

Our goal is to develop a risk-classification tool to identify post-menopausal women who are at high or elevated risk for epithelial ovarian cancer (EOC). We will develop and validate a risk-assessment decision rule based on serum markers as well as epidemiologic risk factors using a split-sample design and data from the Womens Health Initiative (WHI) Observational Study (OS), the WHI Clinical Trial (CT) and the Prostate, Lung, Colon and Ovary (PLCO) trial.

Specifi Aims:
Aim 1: Using a randomly selected fraction of women participating in the WHI OS, WHI CT and the PLCO trial, develop decision rules to identify women at elevated risk for EOC and HGSC using epidemiologic variables alone. Using the remaining women from each study, validate each decision rule within each population.

Aim 2: Cross-validate the decision rules developed in Aim 1 to identify the rule that best identifies women at elevated risk for EOC and HGSC across the 3 different populations. This aim will identify the best epidemiologic decision rule for use in the overall decision rule to be validated in Aim 3.

Aim 3: Using nested case-control study serum marker data as well as epidemiologic data from each study, validate the best decision rule from Aim 2 in combination with the serum marker component of the rule to identify women at elevated and high-risk for EOC and HGSC in each of those populations. In this aim we will validate the final decision rule that incorporates both epidemiologic risk factors and serum markers (the PI has EEMS approval and is currently generating the serum marker data).

Collaborators

Charles Drescher, Fred Hutchinson Cancer Research Center
Garnet Anderson, Fred Hutchinson Cancer Research Center
Kathy O'Briant, Fred Hutchinson Cancer Research Center
Amanda Black, National Cancer Institute