OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

Study Overview
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Brief Summary
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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
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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

Official Title
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OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

Conditions
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Colon Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery Exclusion Criteria: Subjects less than 18 years of age Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma Autoimmune disorders diagnosed subjects Hematological malignancies Subjects under active chemotherapy treatment or chemotherapy in the past 6 months Steroid treatment in the past 3 months Subject undergoing immunosuppressive treatments Subject with verified melanoma colon cancer Subject with verified sarcoma colon cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy_0<br>healthy, people with normal (negative) colonoscopy results. | |
| patient_1<br>people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ | |
| benign_2<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each of the clinicaly defined groups (0,1 and 2). |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, cancer associated auto antibodies, colon cancer blood test