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You are here: Home / Protocols / SPORE/EDRN/PRE-PLCO Ovarian Phase II Validation Study

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

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FHCRC: CA125, HE4, Mesothelin (SMRP), SLPI , Spondin, Cadherin-6, B7-H4, CD-24, IGF2, CHI3L1, DcR3, CA15-3, CA72-4, CA19-9. MD Anderson: Hepcidin, ITIH4, CTAPIII, B2-microglobulin, Transferring, Transthyretin, apolipoprotein A1. Pittsburgh: CA125, Prolactin, MIF, TSH, IGF-BP1, CYFRA21.1, Eotaxin, sVCAM-1, MMP-2, IL-6, IL-2R, IL-8, EGFR, GH, Leptin. MGH: CA125, CA72.4, CA19.9, CA15.3, CEA, HE4, SMRP, B7-H4, DcR3, Spondin-2, IGF-2, CHI3L1.
Case/control
Hypermethylation
Proteomics
Breast and Gynecologic Cancers Research
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Phase II specimens from 160 ovarian cancer cases and 640 benign disease or general population controls were assembled from four Early Detection Research Network (EDRN) or Ovarian Cancer Specialized Program of Research Excellence (SPORE) sites and used to rank 51 biomarkers. Top markers in phase II specimens included CA125, HE4, transthyretin, CA15.3, and CA72.4 with sensitivity at 95% specificity ranging from 0.73 to 0.40.

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.
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.

2015 Steering Committee Meeting

The next EDRN Steering Committee Meeting will take place March 31st through April 2nd, 2015, in Atlanta, Georgia.

Announcement 12/02/2014

New Round of EDRN FOAs

The RFAs for EDRN have been released:
- Biomarker Developmental Laboratories (U01),
- Clinical Validation Centers (U01),
- Biomarker Reference Laboratories (U24),
- Data Management and Coordinating Center (U24).

EDRN Renewal flyer NOTE-New receipt deadline for applications submitted for all EDRN FOAs is January 20, 2015, by 5:00 PM local time of applicant organization.

There will be a Pre-Application webinar to discuss each of the four individual EDRN FOAs on Tuesday, December 2nd, 2014, from 1pm-5pm (Eastern). Potential applicants interested in participating in the webinar should send a message to Dr. Sharmistha Ghosh (ghoshjanjigias@mail.nih.gov) no later than 5:00 p.m. (EST) November 21, 2014. Please mention the FOA of interest in the subject line.

Announcement 10/07/2014

EDRN Patient Advocates will host an EDRN Advocacy Educational Webinar, Biomarkers for Prostate Cancer Detection and Monitoring, on Monday, January 12th, 2015, at 1 p.m. EDT / 10 a.m. PDT. Registration is not required for this. Please click for more information.