Microbiome Test for the Detection of Colorectal Polyps and Cancer

NCT02141945 | Completed

• 1 other identifier: MB-01
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Neoplasms; Colorectal Cancer

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

Outcome Measures

Primary Outcomes (1)

• Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay

  Microbiome based predictions from at least 100 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.

  1 year

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.

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.

Sponsors & Collaborators

• Metabiomics Corp: lead

Study Sites (2)

DC Endoscopy Center

Washington D.C., District of Columbia, 20006, United States

Location

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815, United States

Location

Related Links

• Click here for more information about the sponsor of this study, Metabiomics.

Biospecimen

Retention: SAMPLES WITH DNA

gut microbiome samples from stool, rectal and colonic mucosa

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Colonic Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Colonic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Robert Hardi, M.D.

  Metropolitan Gastroenterology Group

  PRINCIPAL INVESTIGATOR

• Louis Korman, M.D.

  Metropolitan Gastroenterology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (2)