Clinical trial · Interventional
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study
Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening
NCT04739722CI-TRIAL-00081208CRC-PREVENTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adenocarcinoma | Adenocarcinoma | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Serrated Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ColoSense | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ColoSense
- description
- All participants were evaluated with ColoSense prior to undergoing a colonoscopy.
- interventionNames
- Diagnostic Test: ColoSense
Primary outcomes (4)
- measure
- ColoSense Sensitivity for Colorectal Cancer (CRC)
- timeFrame
- 120 days from stool sample collection
- measure
- ColoSense Sensitivity for Advanced Adenoma (AA)
- timeFrame
- 120 days from stool sample collection
- measure
- ColoSense Sensitivity for Serrated Precancerous Lesions (SPL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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 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
References
Publications (1)
- RESULTBarnell EK, Wurtzler EM, La Rocca J, Fitzgerald T, Petrone J, Hao Y, Kang Y, Holmes FL, Lieberman DA. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. doi: 10.1001/jama.2023.22231. PMID 37870871