OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02066259|
Recruitment Status : Unknown
Verified August 2014 by Eventus Diagnostics Ltd.
Recruitment status was: Recruiting
First Posted : February 19, 2014
Last Update Posted : August 5, 2014
|Condition or disease|
The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -
- Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
- 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 -
- For the OctavaGold - 95% specificity with at least 50% sensitivity.
- 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
|Study Type :||Observational|
|Estimated Enrollment :||1080 participants|
|Observational Model:||Case Control|
|Official Title:||OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2018|
healthy, people with normal (negative) colonoscopy results.
people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ
people with biopsy verified benign polyps of the colon one of the following - Villus adenoma, Tubular adenoma, Low grade dysplasia, Intermediate grade dysplasia, High grade dysplasia, Severe dysplasia
- Number of participants in each of the clinicaly defined groups (0,1 and 2). [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066259
|Contact: Galit Yahalom, Ph.Demail@example.com|
|Soroka Medical Center||Not yet recruiting|
|Beer Sheva, Israel, 85025|
|Contact: Gilbert Sabag, MD GilbertS@clalit.org.il|
|Principal Investigator: Gilbert Sabag, MD|
|"Carmel" Medical Center||Not yet recruiting|
|Haifa, Israel, 34362|
|Contact: Arie Bitterman, MD firstname.lastname@example.org|
|Principal Investigator: Arie Bitterman, MD|
|Sub-Investigator: Lilly Merdler, MD|
|Sub-Investigator: Dabbah Kamal, MD|
|Sheba Tel hashomer||Recruiting|
|Ramat gan, Israel, 52621|
|Contact: Adi Lahat, MD Adi.Lahat@sheba.health.gov.il|
|Principal Investigator: Adi Lahat, MD|
|Study Director:||Galit Yahalom, Ph.D.||Eventus Dx|