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Microbiome Test for the Detection of Colorectal Polyps and Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Metabiomics Corp
ClinicalTrials.gov Identifier:
NCT02141945
First received: May 14, 2014
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition
Colorectal Neoplasms Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabiomics Neoplasia Clinical Research Study

Resource links provided by NLM:


Further study details as provided by Metabiomics Corp:

Primary Outcome Measures:
  • Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
gut microbiome samples from stool, rectal and colonic mucosa

Enrollment: 260
Actual Study Start Date: March 2014
Study Completion Date: March 1, 2017
Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02141945

Locations
United States, District of Columbia
DC Endoscopy Center
Washington, District of Columbia, United States, 20006
United States, Maryland
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States, 20815
Sponsors and Collaborators
Metabiomics Corp
Investigators
Principal Investigator: Robert Hardi, M.D. Metropolitan Gastroenterology Group
Principal Investigator: Louis Korman, M.D. Metropolitan Gastroenterology Group
  More Information

Additional Information:
Responsible Party: Metabiomics Corp
ClinicalTrials.gov Identifier: NCT02141945     History of Changes
Other Study ID Numbers: MB-01
Study First Received: May 14, 2014
Last Updated: March 27, 2017

Keywords provided by Metabiomics Corp:
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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 18, 2017