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

Colorectal Cancer Clinical Trial

— CRC-PREVENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04739722
• Other study ID #: Pro00045815
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: September 22, 2023

Study information

• Verified date: May 2023
• Source: Geneoscopy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Advanced Adenocarcinoma
• Colonic Polyps
• Colorectal Cancer
• Colorectal Neoplasms
• Polyp of Colon

Intervention

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.

Locations

Country	Name	City	State
United States	Elligo Health Research	Austin	Texas
United States	Geneoscopy, Inc.	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Geneoscopy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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, a — View Citation

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External 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.