Metabiomics Colon Cancer Clinical Research Study

August 14, 2018 updated by: Metabiomics Corp
The specific aim of the study is to determine the false negative rate of the Metabiomics Colon Polyp and Colorectal Cancer Assay for Cancer.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
immediately post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metabiomics Corp

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-02_CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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