Microbiome Test for the Detection of Colorectal Polyps and Cancer

Completed

Conditions studied: Colorectal Neoplasms, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT02141945

Run by

Metabiomics Corp

People needed

260

Starts

2014-03-01

Expected to finish

2017-03-01

Last updated by the study team

2017-03-28

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• DC Endoscopy Center — Washington D.C., District of Columbia, United States
• Chevy Chase Endoscopy Center — Chevy Chase, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.