NCT04739722Completed
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study
Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14263 (actual)
- First submitted
- 11 Sept 2020
- Start date
- 12 Apr 2021
- Primary completion date
- 27 Oct 2022
- Lead sponsor
- Geneoscopy, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT04739722
What you commit to
- Study type: Interventional
- Participants enrolled: 14263
- From 12 Apr 2021 to the primary completion date, 27 Oct 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Subject has a history or diagnosis of colorectal cancer
- Subject has a history of aerodigestive tract cancer
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elligo Health Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Geneoscopy, Inc. Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.