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Trial record 14 of 3841 for:    colon cancer AND Intestinal Neoplasms

Microbiome Test for the Detection of Colorectal Polyps and Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141945
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Metabiomics Corp

Tracking Information
First Submitted Date May 14, 2014
First Posted Date May 20, 2014
Last Update Posted Date March 28, 2017
Actual Study Start Date March 2014
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02141945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbiome Test for the Detection of Colorectal Polyps and Cancer
Official Title Metabiomics Neoplasia Clinical Research Study
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
gut microbiome samples from stool, rectal and colonic mucosa
Sampling Method Non-Probability Sample
Study Population Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.
Condition
  • Colorectal Neoplasms
  • Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 27, 2017)
260
Original Estimated Enrollment
 (submitted: May 15, 2014)
200
Actual Study Completion Date March 1, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02141945
Other Study ID Numbers MB-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Metabiomics Corp
Study Sponsor Metabiomics Corp
Collaborators Not Provided
Investigators
Principal Investigator: Robert Hardi, M.D. Metropolitan Gastroenterology Group
Principal Investigator: Louis Korman, M.D. Metropolitan Gastroenterology Group
PRS Account Metabiomics Corp
Verification Date March 2017