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You are here: Home / Protocols / Phase II Validation of a New Panel of Biomarkers for Early Detection of Ovarian Cancer

Phase II Validation of a New Panel of Biomarkers for Early Detection of Ovarian Cancer

Mor, GilYale University
Feng, ZidingFred Hutchinson Cancer Research Center
Prolactin, Leptin, IGF-11, OPN MIF, CA-125
Breast and Gynecologic Cancers Research

While all cancer patients could potentially benefit from earlier detection and prevention, the development of new screening technologies and chemoprevention for epithelial ovarian cancer (EOC) is unique in this regard. EOC is characterized by few early symptoms, presentation at an advanced stage, and poor survival. Presently there is no commercially available test that is diagnostic for either early or advanced stage epithelial ovarian cancer. The most commonly used marker, CA125, identifies a group of cell surface glycoproteins, which have uncertain biological behavior and very limited clinical utility for the detection of early stage disease. In recent years, several approaches have been used in order to develop a test for early detection, including the analysis of serum samples by SELDI-TOF and MALDI-TOF to find proteins or protein fragments of unknown identity that detect the presence/absence of cancer. Unfortunately, at the present time, none of these techniques have been shown to be adequate. Therefore, the development of a test that can detect early stages of the disease could dramatically improve treatment success and long-term survival. 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 the results with different techniques. Using split point analysis with four markers, 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 individuals were diagnosed incorrectly (5.6%). Working in collaboration with the Early Detection Network (EDRN/NCI/NIH), we performed Phase I discovery study confirming the potential application of this test for early detection of ovarian cancer (Preliminary results). The main objective of this pr

Aim 1. To validate the Yale Early Detection Assay (YEDA) in a Phase II Validation Trial consisting of a case control study for patients with ovarian cancer. Aim 2. To determine whether the Luminex platform and the inclusion of three additional markers will increase the sensitivity and specificity of the test.
The concentration of the four markers will be measured in the serum using a sandwich ELISA. For the Phase II validation study all the tests will be performed by LabCorp, which has completed the process of validation and standardization of the four analytes. The Luminex platform will be evaluated at Yale. The specimen will be blinded to all labs on disease status. The blinded labels will be provided by EDRN/DMCC. The assay data will be sent to EDRN/DMCC.

No datasets are currently associated with this protocol.

Announcement 10/23/2017

Three new FOAs on the Human Tumor Atlas and associated with the Cancer Moonshot Initiative have been released. Please click here for more information.

10th Science Workshop
Thank you to everyone who made the 32nd EDRN Steering Committee meeting a success. The next event is the 10th EDRN Scientific Workshop from March 6-8, 2018 in Bethesda, MD. Click to view the flyer; click to visit the registration page.
EDRN Founder Honored

Dr. Sudhir Srivastava was honored with the Distinguished Service Award from the American Pancreatic Association at the group's annual meeting this year, for his outstanding commitment to pancreatology.