Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (CRC-PREVENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04739722|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2021
Last Update Posted : August 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Advanced Adenocarcinoma Adenoma Colon Polyp of Colon||Diagnostic Test: Colonosight Stool Sample Collection Kit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColonoSight test, which is a multi-target stool RNA test for colorectal screening. Patients who are eligible for a colonoscopy (i.e., asymptomatic, 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 ColonoSight 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 ColonoSight test.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 12, 2021|
|Estimated Primary Completion Date :||August 22, 2022|
|Estimated Study Completion Date :||August 22, 2022|
Experimental: ColonoSight Test
All participants will be evaluated with the Colonosight Test system and a colonoscopy.
Diagnostic Test: Colonosight Stool Sample Collection Kit
The ColonoSight 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 ColonoSight 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 ColonoSight test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the ColonoSight Collection Kit will also be read by laboratory technologists at Geneoscopy.
- ColonoSight sensitivity for subjects with CRC [ Time Frame: 1 year ]ColonoSight 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.
- ColonoSight sensitivity for subjects with Advanced Adenoma (AA) [ Time Frame: 1 year ]ColonoSight sensitivity for subjects with AA, which is the percentage of individuals with a diagnosis of advanced adenoma that were detected as positive by the ColonoSight test.
- ColonoSight sensitivity for subjects with high-grade dysplasia [ Time Frame: 1 year ]ColonoSight 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 ColonoSight test.
- ColonoSight sensitivity for subjects with Other Adenomas (OAs) [ Time Frame: 1 year ]ColonoSight 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 ColonoSight test.
- ColonoSight specificity for subjects with negative findings [ Time Frame: 1 year ]ColonoSight 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 ColonoSight test.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||45 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739722
|United States, Missouri|
|Saint Louis, Missouri, United States, 63146|
|United States, Texas|
|Elligo Health Research|
|Austin, Texas, United States, 78738|
|Study Chair:||Elizabeth Wurtzler, PhD||Geneoscopy, Inc.|
|Principal Investigator:||Faith Holmes, MD||Elligo Health Research|
Publications of Results:
|Responsible Party:||Geneoscopy, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 5, 2021 Key Record Dates|
|Last Update Posted:||August 26, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical