Colon Cancer Clinical Trial
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study
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., 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.
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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Saint Louis Missouri, 63146, United States
Austin Texas, 78738, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.