Spots Global Cancer Trial Database for Microbiome Test for the Detection of Colorectal Polyps and Cancer
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Trial Identification
Brief Title: Microbiome Test for the Detection of Colorectal Polyps and Cancer
Official Title: Metabiomics Neoplasia Clinical Research Study
Study ID: NCT02141945
Interventions
Study Description
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.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
DC Endoscopy Center, Washington, District of Columbia, United States
Chevy Chase Endoscopy Center, Chevy Chase, Maryland, United States
Contact Details
Name: Robert Hardi, M.D.
Affiliation: Metropolitan Gastroenterology Group
Role: PRINCIPAL_INVESTIGATOR
Name: Louis Korman, M.D.
Affiliation: Metropolitan Gastroenterology Group
Role: PRINCIPAL_INVESTIGATOR
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