Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

Study Overview
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Brief Summary
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This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the Colosense test, which is a multi-target stool RNA test for colorectal screening.

Detailed Description
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Patients who are eligible for a colonoscopy (i.e., average risk individuals 45 years of age and older 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 Colosense 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 Colosense test.

Official Title
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Clinical Validation of the ColonoSight Test: a Multi-target Stool RNA (Mt-sRNA) Assay for Colorectal Neoplasia Screening in Average-risk Individuals Aged >45 Years Old

Conditions
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Colorectal Cancer, Advanced Adenocarcinoma, Adenoma Colon, Polyp of Colon

Intervention / Treatment
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* Diagnostic Test: Colosense Stool Sample Collection Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female, >45 years of age Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure. Subject is able and willing to undergo a colonoscopy after providing a stool sample Exclusion Criteria: Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable) Subject has a history or diagnosis of colorectal cancer Subject has a history of aerodigestive tract cancer Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months FIT-DNA test within the previous 36 months Subject has had a colonoscopy in the previous nine (9) years. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding) Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer: Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP) Hereditary non-polyposis colorectal cancer syndrome (also referred to as HNPCC of Lynch Syndrome) Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis

Ages Eligible for Study
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Minimum Age: 45 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the Colosense test, which is a multi-target stool RNA test for colorectal screening. Patients who are eligible for a colonoscopy (i.e., 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 Colosense 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 Colosense test.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colosense Test<br>All participants will be evaluated with the Colosense Test system and a colonoscopy. | Diagnostic Test: Colosense Stool Sample Collection Kit<br>* The Colosense Collection Kit provides information on how to collect a stool swab using a fecal immunochemical test (FIT) and how to collect a stool sample using the Colosense Collection Kit. After a stool sample is produced, patients will swab the stool sample using the FIT tube according to instructions and return the stool sample via mail courier to Geneoscopy's Laboratories. Patients will then be directed to receive a colonoscopy. If a lesion is removed during the colonoscopy, the tissue sample will be sent for histopathology review. The colonoscopy report and the histopathology report will be reported to Geneoscopy. Stool samples returned to Geneoscopy's Laboratories will be subjected to the Colosense test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the Colosense Collection Kit will also be read by laboratory technologists at Geneoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colosense sensitivity for subjects with CRC | Colosense sensitivity for subjects with CRC, which is the percentage of individuals with a diagnosis of colorectal cancer that were detected as positive by the ColonoSight test. | 1 year | 
| Colosense sensitivity for subjects with Advanced Adenoma (AA) | Colosense sensitivity for subjects with AA, which is the percentage of individuals with a diagnosis of advanced adenoma that were detected as positive by the Colosense test. | 1 year | 
| Colosense sensitivity for subjects with high-grade dysplasia | Colosense sensitivity for subjects with high-grade dysplasia, which is the percentage of individuals with a diagnosis of carcinoma in situ or advanced adenoma with high grade dysplasia that were detected as positive by the Colosense test. | 1 year | 
| Colosense sensitivity for subjects with Other Adenomas (OAs) | Colosense sensitivity for subjects with Other Adenomas (OAs), which is the percentage of individuals with a diagnosis of a non-advanced precancerous adenoma that were detected as positive by the Colosense test. | 1 year | 
| Colosense specificity for subjects with negative findings | Colosense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of benign polyps, or no findings on a colonoscopy that were detected as negative by the Colosense test. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma, Polyp