Microbiome Test for the Detection of Colorectal Polyps and Cancer

Completed

• Conditions: Colorectal Neoplasms; Colorectal Cancer

• Registration Number: NCT02141945
• Lead Sponsor: Metabiomics Corp

Brief Summary

The purpose if this study is to measure the sensitivity, specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer.

Detailed Description

The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer. Microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-20
• Status Verified: 2017-03
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Male or female,
• Age: 45-80 years,
• Patients undergoing polyp surveillance or screening colonoscopy who are ASA Class 1-3. No ASA Class 4 or 5 will be included.Footnote
• All ethnic and racial groups will be included,
• Able to comprehend, sign, and date the written informed consent form (ICF),
• Able to give informed consent in English.

Exclusion Criteria

• History of Inflammatory Bowel Disease
• Inability to schedule the colonoscopy within 60 days of the initial stool sample
• Colonic pathology that in the opinion of the endoscopist could interfere with the accuracy of the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
• ASA class 4 or greater
• Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay	1 year	Microbiome based predictions from at least 100 blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.

Trial Locations

Locations (2)

DC Endoscopy Center; 🇺🇸 Washington, District of Columbia, United States

Chevy Chase Endoscopy Center; 🇺🇸 Chevy Chase, Maryland, United States