Clinical trial NCT02141945: Microbiome Test for the Detection of Colorectal Polyps and Cancer
Official title: Metabiomics Neoplasia Clinical Research Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Metabiomics Corp
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 260
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.

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.

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 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.

Primary outcomes:
measure: Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC Endoscopy Center
state: District of Columbia
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
Study officials:
affiliation: Metropolitan Gastroenterology Group
name: Robert Hardi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Metropolitan Gastroenterology Group
name: Louis Korman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: