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

Completed · Not applicable

Conditions studied: Colorectal Cancer, Advanced Adenocarcinoma, Serrated Polyp

In brief

This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.

Key facts

Study ID

NCT04739722

Run by

Geneoscopy, Inc.

People needed

14263

Starts

2021-04-12

Expected to finish

2024-01-31

Last updated by the study team

2024-10-01

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Subject had any precancerous finding 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

Where it is running

• Geneoscopy, Inc. — St Louis, Missouri, United States
• Elligo Health Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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