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

NCT04739722 | Completed Results DMC FDA Device

• 1 other identifier: Pro00045815
• Study Type: interventional
• Target: 14,263
• Locations: 1 country
• Sites: 2

Brief Summary

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

Colorectal Cancer; Advanced Adenocarcinoma; Serrated Polyp

Outcome Measures

Primary Outcomes (4)

• ColoSense Sensitivity for Colorectal Cancer (CRC)

  120 days from stool sample collection

• ColoSense Sensitivity for Advanced Adenoma (AA)

  120 days from stool sample collection

• ColoSense Sensitivity for Serrated Precancerous Lesions (SPL)

  120 days from stool sample collection

• ColoSense Specificity for Negative Findings

  120 days from stool sample collection

Study Arms (1)

ColoSense

EXPERIMENTAL

All participants were evaluated with ColoSense prior to undergoing a colonoscopy.

Diagnostic Test: ColoSense

Interventions

ColoSense DIAGNOSTIC_TEST

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

ColoSense

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Geneoscopy, Inc.: lead

Study Sites (2)

Geneoscopy, Inc.

St Louis, Missouri, 63146, United States

Location

Elligo Health Research

Austin, Texas, 78738, United States

Location

Related Publications (1)

• Barnell 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 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Chief Medical and Science Officer
• Organization: Geneoscopy Inc.

contact@geneoscopy.com

314-887-7777

Study Officials

• Faith Holmes, MD

  Elligo Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. Subjects were recruited onto the clinical trial if they were average-risk subjects, or had a self-reported family history of CRC, aged 45 and older. All participants completed the ColoSense test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The ColoSense test result (positive or negative) was compared with index lesions observed on colonoscopy. The primary outcomes included ColoSense sensitivity for detecting colorectal cancer, advanced adenomas, or serrated precancerous lesions, and ColoSense specificity for all other findings.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: February 5, 2021
• Study Start: April 12, 2021
• Primary Completion: October 27, 2022
• Study Completion: January 31, 2024
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)