SPORE/EDRN/PRE-PLCO Ovarian Phase II Validation Study

Abbreviated Name
OVAR-VAL-PRE-PLCO
Lead Investigator
Cramer, Daniel — Brigham and Womens Hospital
Coordinating Investigator
Zheng, Yingye — Fred Hutchinson Cancer Center
Involved Investigators

Abstract

see objectives

Aims

1. Retest all of the biomarkers that have performed well in preliminary studies in a newly-assembled test set of 160 cases with pre-operative bloods representing major histologic types and including 80 early-staged and 80 late-staged cases, 160 controls with benign disease, 480 general population controls, and a small set of serial Samples collected either at least 3 months apart, but not more than 6 months apart OR between 10 months apart and no more than 14 months apart in 40 healthy controls. 2. Evaluate the reproducibility, concordance with standard ELISA, and performance of the bead-based (Luminex) assays. 3. Identify a consensus panel comprising the biomarkers that are most informative on their own as well as those that are most complementary when used together, and that can be evaluated in no more than .3 ml of serum using the Luminex platform, and up to 5 additional markers that can be measured adequately only by standard ELISA.

Analytic Method

Based upon comprehensive reviews of ovarian cancer biomarkers and preliminary studies in which multiple biomarkers have been compared simultaneously, investigators representing Ovarian Cancer SPORES, EDRN and the PLCO trial are working towards defining a consensus panel of biomarkers appropriate for ovarian cancer screening. Towards this goal, SPORE and EDRN investigators proposed to assemble a new set of phase II specimens (160 ovarian cancer cases with pre-operative bloods over-sampled for early-stage disease, 160 benign disease controls, 480 general population controls, and serial samples collected one year apart from 40 healthy women). The top 5 markers identified in preliminary work by Boston-NW and FHCRC investigators, plus an expanded panel of Luminex markers, were evaluated to identify a final consensus panel of 5 to 15 biomarkers. CA125 and the top 5 new markers were measured by standard ELISA using an automated platform, or kit, at BWH. CA125 and the top 5 new markers, as well as additional candidate markers unique to each institution, were measured using Luminex at FHCRC and Pittsburgh. Results from ELISA were compared to results obtained from Luminex to evaluate the consistency of CA125 and the top 5 new markers across platforms and institutions. Markers were selected for inclusion in the panel based on their individual performance, their contribution to a panel, and their stability over time, where the last predicts the improvement in performance expected from their use in a longitudinal algorithm. For markers that could be measured adequately on Luminex, to preserve specimen volume, the Luminex platform was used to evaluate the final consensus panel in the requested PLCO specimens; standard ELISA were used only if necessary due to inadequate measurement by Luminex.

Outcome

see objectives

Publications

Biomarkers

Data Collections

Start Date
Aug 15 2005
Estimated Finish Date
Aug 1 2007
Finish Date
Oct 23 2007
Protocol ID
119
Protocol Type
Validation
Fields of Research
  • Hypermethylation
  • Proteomics
Collaborative Group
Breast and Gynecologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of ovary
Phased Status
2

Associated Forms