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Metabiomics Colon Cancer Clinical Research Study

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ClinicalTrials.gov Identifier: NCT02151123
Recruitment Status : Not yet recruiting
First Posted : May 30, 2014
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Metabiomics Corp

Brief Summary:
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.

Condition or disease
Colonic Neoplasms

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 case several types of gut microbiome samples will be collected from patients undergoing colectomy for colonic adenocarcinoma; those samples will be tested by Metabiomics Colon Polyp and Colorectal Cancer Assay and the percentage of false negative (test returns a negative for cancer) results determined.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Metabiomics Colon Cancer Clinical Research Study
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Group/Cohort
Diagnosed colon cancer patients
Patients undergoing colectomy for colonic adenocarcinoma.



Primary Outcome Measures :
  1. False negative rate of test for colon cancer [ Time Frame: immediately post surgery ]
    The False Negative Rate is calculated as (100*False Negative) /(True Positive + False Negative).


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado
Criteria

Inclusion Criteria:

  • Recently diagnosed with colorectal cancer (CRC) and scheduled for colectomy
  • Male or female,
  • Age: 18-95 years,
  • Able to comprehend, sign, and date the written informed consent form (ICF),
  • Able to give informed consent in English
  • Women and minorities will be included.

Exclusion Criteria:

  • History of Inflammatory Bowel Disease
  • Antibiotics within 2 weeks of sample collection.
  • Colonoscopy, colon prep or bowel contrast agent within 7 days prior to sample collection
  • Any radiation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151123


Contacts
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Contact: Tracey MacDermott 303-724-2757 tracey.macdermott@ucdenver.edu

Locations
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United States, Colorado
University of Colorado School of Medicine Anschutz Medical Campus Not yet recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Metabiomics Corp
Investigators
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Principal Investigator: Jon Vogel, MD University of Colorado School of Medicine Anschutz Medical Campus
Principal Investigator: Christopher Lieu, MD University of Colorado School of Medicine Anschutz Medical Campus
Principal Investigator: Patrick Gillevet, PhD George Mason University

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Responsible Party: Metabiomics Corp
ClinicalTrials.gov Identifier: NCT02151123     History of Changes
Other Study ID Numbers: MB-02_CU
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Keywords provided by Metabiomics Corp:
Colonic Neoplasms
Colon Cancer
Microbiome

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