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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
May 14, 2014
March 27, 2017
March 2014
March 1, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02141945 on ClinicalTrials.gov Archive Site
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Microbiome Test for the Detection of Colorectal Polyps and Cancer
Metabiomics Neoplasia Clinical Research Study
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
gut microbiome samples from stool, rectal and colonic mucosa
Non-Probability Sample
Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.
  • Colorectal Neoplasms
  • Colorectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
March 1, 2017
March 1, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
45 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02141945
MB-01
No
Not Provided
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Metabiomics Corp
Metabiomics Corp
Not Provided
Principal Investigator: Robert Hardi, M.D. Metropolitan Gastroenterology Group
Principal Investigator: Louis Korman, M.D. Metropolitan Gastroenterology Group
Metabiomics Corp
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP