Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 8600
Summary
- Conditions
- Adenoma Colon
- Advanced Adenocarcinoma
- Colorectal Cancer
- Polyp of Colon
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColonoSight test, which is a multi-target stool RNA test for colorectal screening. Patients who are eligible for a colonoscopy (i.e., asymptomatic, average risk individuals between 45-80 who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the ColonoSight test system, and a result will be generated. The result will be compared to an optical colonoscopy to determine: 1) sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and 2) specificity for hyperplastic polyps and no findings on a colonoscopy. This study will be used for the clinical validation of the ColonoSight test.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 45 years and 125 years
- Gender
- Both males and females
Description
Patients who are eligible for a colonoscopy (i.e., asymptomatic, average risk individuals 45-84 years of age who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the ColonoSight te...
Patients who are eligible for a colonoscopy (i.e., asymptomatic, average risk individuals 45-84 years of age who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the ColonoSight test system, and a result will be generated. The result will be compared to an optical colonoscopy to determine: 1) sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and 2) specificity for hyperplastic polyps and no findings on a colonoscopy. This study will be used for the clinical validation of the ColonoSight test.
Tracking Information
- NCT #
- NCT04739722
- Collaborators
- Not Provided
- Investigators
- Study Chair: Elizabeth Wurtzler, PhD Geneoscopy, Inc. Principal Investigator: Faith Holmes, MD Elligo Health Research
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