Gil Mor

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PLCO (Learn more about this study)

2006-0279

Nov 21, 2006

Validation of Serum Markers for early Detection of Ovarian Cancer

The development of a test that can detect early stages of the ovarian cancer could dramatically improve treatment success and long-term survival. In recent years, several approaches have been used in order to develop a test for early detection, unfortunately, none of these techniques have been shown to be adequate. We have developed a new blood test based on a different approach: 1) we used known proteins related to cancer biology, 2) we characterized these proteins with several different screening steps using samples obtained from both healthy and cancer patient populations, and 3) validated with different techniques. Using split point analysis with four markers identified, 96 out of 100 EOC patients (96%) were correctly diagnosed with ovarian cancer (including 23 of 24 patients with Stage I/II EOC). In the healthy group 6 out of 106 individual were diagnosed incorrectly (5.6%).
The main objective of this proposal is to validate the accuracy of the results of the Yale Early Detection Assay (YEDA) in the detection of early stages of ovarian cancer. Furthermore, we hypothesize that the addition of proteins found to be differentially
expressed to the test might increase the sensitivity and specificity of the assay. The objectives of this proposal are the following:
Aim 1. To validate the Yale Early Detection Assay (YEDA) in a bigger cohort of patients with ovarian cancer and high risk population.
Aim 2 To determine whether the addition of MIF will increase the sensitivity and specificity of the test.
The data presented in our preliminary studies support the existence of a highly accurate and distinct multiplex proteomic set that can accurately distinguish between normal and EOC patients, including stage I and II. This proposal will facilitate moving this assay from the bench to clinical screening.