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Brief Title: OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Official Title: OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Study ID: NCT02066259
Brief Summary: The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population
Detailed Description: The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis - 1. Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population. 2. Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population. The study will be considered successful it can achieve at least one of the following sets of performances - 1. For the OctavaGold - 95% specificity with at least 50% sensitivity. 2. For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Soroka Medical Center, Beer Sheva, , Israel
"Carmel" Medical Center, Haifa, , Israel
Sheba Tel hashomer, Ramat gan, , Israel
Name: Galit Yahalom, Ph.D.
Affiliation: Eventus Dx
Role: STUDY_DIRECTOR