Back to results

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

Primary Purpose

Colorectal Cancer, Advanced Adenocarcinoma, Adenoma Colon

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Colosense Stool Sample Collection Kit

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Adenoma, Polyp

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Geneoscopy, Inc.
Elligo Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colosense Test

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04739722

First Posted

September 11, 2020

Last Updated

May 11, 2023

Sponsor

Geneoscopy, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04739722

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 12, 2021 (Actual)

Primary Completion Date

September 22, 2023 (Anticipated)

Study Completion Date

September 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Geneoscopy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Advanced Adenocarcinoma, Adenoma Colon, Polyp of Colon

Keywords

Adenoma, Polyp

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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. Patients who are eligible for a colonoscopy (i.e., average risk individuals between 45-80 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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colosense Test

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Colosense Stool Sample Collection Kit

Intervention Description

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.

Primary Outcome Measure Information:

Title

Colosense sensitivity for subjects with CRC

Description

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.

Time Frame

1 year

Title

Colosense sensitivity for subjects with Advanced Adenoma (AA)

Description

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.

Time Frame

1 year

Title

Colosense sensitivity for subjects with high-grade dysplasia

Description

Time Frame

1 year

Title

Colosense sensitivity for subjects with Other Adenomas (OAs)

Description

Time Frame

1 year

Title

Colosense specificity for subjects with negative findings

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Wurtzler, PhD

Organizational Affiliation

Geneoscopy, Inc.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Faith Holmes, MD

Organizational Affiliation

Elligo Health Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geneoscopy, Inc.

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63146

Country

United States

Facility Name

Elligo Health Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78738

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31154021

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: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available.

Results Reference

result

PubMed Identifier

34029233

Citation

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.

Results Reference

result

Links:

URL

http://doi.org/10.1053/j.gastro.2019.05.058

Description

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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs