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
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Adenoma, Polyp
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
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
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
No
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
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.
Time Frame
1 year
Title
Colosense sensitivity for subjects with Other Adenomas (OAs)
Description
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.
Time Frame
1 year
Title
Colosense specificity for subjects with negative findings
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
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
No
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
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