Microbiome Test for the Detection of Colorectal Polyps and Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Neoplasms Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes