Microbiome Test for the Detection of Colorectal Polyps and Cancer
Conditions
Colorectal Neoplasms - Colorectal Cancer
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
Cancer, Colon Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Colonic Diseases, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 45 Years
Gender: Both
Criteria: 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.
Locations
DC Endoscopy Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Louis Korman, M.D. - 301-652-5520 - louis.korman@capitaldigestivecare.com
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States
Status: Recruiting
Contact: Louis Korman, M.D. - 301-652-5520 - louis.korman@capitaldigestivecare.com
Start Date
March 2014
Completion Date
June 2015
Sponsors
Metabiomics Corp
Source
Metabiomics Corp
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page