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Multiplexed Assay of Serum Biomarkers for Ovarian Cancer

Principal Investigator
Name
Anna Lokshin
Degrees
-
Institution
University of Pittsburgh
Position Title
-
Email
About this CDAS Project
Study
PLCO (Learn more about this study)
Project ID
2006-0290
Title
Multiplexed Assay of Serum Biomarkers for Ovarian Cancer
Summary
Ovarian cancer is the fourth most frequent cause of death from cancerin women in Europe and the United States (1-3). Since ovarian cancers typicallycause few specific symptoms more than 70% of patients are diagnosed when they have advanced disease and for these patients, 5-year survival ratesare less than 20% (1, 3). In contrast, the 25% of patients, who arediagnosed with stage I disease, have a 5-year survival rate of over 80% (2, 3). Therefore, early detection of ovarian cancer has great promise to improve clinical outcome. We have identified a serological multi-biomarker panel that discriminates early stages ovarian cancer from healthy control with a sensitivity of 90% at 98% specificity in a blinded independent case/control set. To the best of our knowledge, this is the highest diagnostic power for such a set reported so far. We propose to validate this set in retrospective longitudinal samples from PLCO in preparation for prospective clinical trial.
Aims

We have identified a 23-biomarker panel that discriminated ovarian cancer cases from healthy controls with a sensitivity of 90% at a specificity of 98% in a case/control independent blinded validation set. We hypothesize that this multi-marker panel would recognize early stages of ovarian cancer with significant (1-2 years) lead time. The objective of this study is to develop a reliable serum-based assay for early detection of ovarian cancer based on the longitudinal patterns of multiple biomarkers. To achieve this objective, we propose to validate this panel in a retrospective longitudinal study (PLCO) using 200 ml of sera from 120 participants who subsequently developed ovarian cancer and 200 ml sera from 3 matched controls who did not develop ovarian cancer per case of cancer. The proposed Specific Aims are 1. Validate data in additional independent test case/control set obtained from PLCO; 2. Develop an algorithm for screening positivity in retrospective study based on combinations of markers; 3. Determine sensitivity, specificity, positive predictive value, and a lead timebefore clinical diagnosis in PLCO longitudinal retrospective samples. Dr. Lokshin is a part of PLCO/EDRN/SPORE group (Drs. Cramer and Urban, PIs), which has been already approved for use of PLCO samples. However, we feel that it is very important to validate the 23-biomarker panel separately and then compare it with the results obtained with PLCO/EDRN/SPORE group. In the present setting, there may be not enough sample volume to ensure that Dr. Lokshin has 200 ml for validation of her panel.

Collaborators

Steven Skates (University of Pittsburgh)
Robert Bast (MD Anderson Cancer Center)
Anna Lokshin (University of Pittsburgh)

Approved Addenda This project has one or more approved addenda.
  • Using residual serum to measure newly discovered candidate biomarkers
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