Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (CRC-PREVENT)

Clinical Validation of the ColonoSight Test: a Multi-target Stool RNA (Mt-sRNA) Assay for Colorectal Neoplasia Screening in Average-risk Individuals Aged >45 Years Old

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

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Polyp of Colon; Adenoma Colon; Advanced Adenocarcinoma
• Intervention / Treatment: Diagnostic test: Colosense Stool Sample Collection Kit

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 8000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63146
      • Geneoscopy, Inc.
  • Texas
    • Austin, Texas, United States, 78738
      • Elligo Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Colosense Test; All participants will be evaluated with the Colosense Test system and a colonoscopy.

Diagnostic test: Colosense Stool Sample Collection Kit; The Colosense Collection Kit provides information on how to collect a stool swab using a fecal immunochemical test (FIT) and how to collect a stool sample using the Colosense Collection Kit. After a stool sample is produced, patients will swab the stool sample using the FIT tube according to instructions and return the stool sample via mail courier to Geneoscopy's Laboratories. Patients will then be directed to receive a colonoscopy. If a lesion is removed during the colonoscopy, the tissue sample will be sent for histopathology review. The colonoscopy report and the histopathology report will be reported to Geneoscopy. Stool samples returned to Geneoscopy's Laboratories will be subjected to the Colosense test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the Colosense Collection Kit will also be read by laboratory technologists at Geneoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colosense sensitivity for subjects with CRC	Colosense sensitivity for subjects with CRC, which is the percentage of individuals with a diagnosis of colorectal cancer that were detected as positive by the ColonoSight test.	1 year
Colosense sensitivity for subjects with Advanced Adenoma (AA)	Colosense sensitivity for subjects with AA, which is the percentage of individuals with a diagnosis of advanced adenoma that were detected as positive by the Colosense test.	1 year
Colosense sensitivity for subjects with high-grade dysplasia	Colosense sensitivity for subjects with high-grade dysplasia, which is the percentage of individuals with a diagnosis of carcinoma in situ or advanced adenoma with high grade dysplasia that were detected as positive by the Colosense test.	1 year
Colosense sensitivity for subjects with Other Adenomas (OAs)	Colosense sensitivity for subjects with Other Adenomas (OAs), which is the percentage of individuals with a diagnosis of a non-advanced precancerous adenoma that were detected as positive by the Colosense test.	1 year
Colosense specificity for subjects with negative findings	Colosense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of benign polyps, or no findings on a colonoscopy that were detected as negative by the Colosense test.	1 year

Collaborators and Investigators

• Sponsor: Geneoscopy, Inc.
• Investigators: Study Chair: Elizabeth Wurtzler, PhD, Geneoscopy, Inc.; Principal Investigator: Faith Holmes, MD, Elligo Health Research

Publications and helpful links

General Publications

• Barnell EK, Kang Y, Wurtzler EM, Griffith M, Chaudhuri AA, Griffith OL; Geneoscopy Scientists. Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers. Gastroenterology. 2019 Sep;157(3):884-887.e3. doi: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available.
• Barnell EK, Kang Y, Barnell AR, Kruse KR, Fiske J, Pittz ZR, Khan AR, Huebner TA, Holmes FL, Griffith M, Griffith OL, Chaudhuri AA, Wurtzler EM. Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasias in a Multicenter, Prospective, and Retrospective Cohort. Clin Transl Gastroenterol. 2021 May 24;12(5):e00360. doi: 10.14309/ctg.0000000000000360.

Helpful Links

• This study used a 275-patient cohort to validate a preliminary clinical sensitivity and specificity for ColonoSight. As part of this study, a machine learning algorithm was developed using 154 samples and 14 features.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): September 22, 2023
• Study Completion (Anticipated): September 22, 2023

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adenoma; Polyp
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Polyps; Intestinal Polyps; Colorectal Neoplasms; Adenoma; Colonic Polyps
• Other Study ID Numbers: Pro00045815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes