NCT02141945

Microbiome Test for the Detection of Colorectal Polyps and Cancer

Metabiomics Neoplasia Clinical Research Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: Metabiomics Corp · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Neoplasms
• Colorectal Cancer

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-05-20
• Last updated: 2017-03-28

Locations

2 sites across 1 country: United States