Validation of Serum Markers for early Detection of Ovarian Cancer
About this CDAS Project
Study
PLCO
(Learn more about this study)
Project ID
2006-0279
Initial CDAS Request Approval
Nov 21, 2006
Title
Validation of Serum Markers for early Detection of Ovarian Cancer
Summary
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.
Aims
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:
Objective 1. To validate the Yale Early Detection Assay (YEDA) in a bigger cohort of patients with ovarian cancer and high-risk population.
Objective 2. To determine whether the addition of MIF will increase the sensitivity and specificity of the test.
Collaborators
Ayesha Alvero (Yale University)
Boris Pasche (Medicine/UAB)
David Ward (Nevada Cancer)
Gil Mor (Yale University Sch Med)
Kui Zhang (Statistical genetics/UAB)
Nengjun Yi (Statistical genetics/UAB)
Peter Schwartz (Yale University)
Richard Myers (Hudson Alpha Institute)
Thomas Rutherford (Yale University)
Ziding Feng (FHCRC)
Related Publications
-
Potential role of HE4 in multimodal screening for epithelial ovarian cancer.
Urban N, Thorpe JD, Bergan LA, Forrest RM, Kampani AV, Scholler N, O'Briant KC, Anderson GL, Cramer DW, Berg CD, McIntosh MW, Hartge P, Drescher CW
J. Natl. Cancer Inst. 2011 Nov; Volume 103 (Issue 21): Pages 1630-4 PUBMED -
A framework for evaluating biomarkers for early detection: validation of biomarker panels for ovarian cancer.
Zhu CS, Pinsky PF, Cramer DW, Ransohoff DF, Hartge P, Pfeiffer RM, Urban N, Mor G, Bast RC, Moore LE, Lokshin AE, McIntosh MW, Skates SJ, Vitonis A, Zhang Z, Ward DC, Symanowski JT, Lomakin A, Fung ET, Sluss PM, ...show more Scholler N, Lu KH, Marrangoni AM, Patriotis C, Srivastava S, Buys SS, Berg CD, PLCO Project Team
Cancer Prev Res (Phila). 2011 Mar; Volume 4 (Issue 3): Pages 375-83 PUBMED -
Ovarian cancer biomarker performance in prostate, lung, colorectal, and ovarian cancer screening trial specimens.
Cramer DW, Bast RC, Berg CD, Diamandis EP, Godwin AK, Hartge P, Lokshin AE, Lu KH, McIntosh MW, Mor G, Patriotis C, Pinsky PF, Thornquist MD, Scholler N, Skates SJ, Sluss PM, Srivastava S, Ward DC, Zhang Z, Zhu CS, ...show more Urban N
Cancer Prev Res (Phila). 2011 Mar; Volume 4 (Issue 3): Pages 365-74 PUBMED