Metabiomics Colon Cancer Clinical Research Study

NCT02151123 | Withdrawn

• 1 other identifier: MB-02_CU
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms

Keywords

Colonic Neoplasms; Colon Cancer; Microbiome

Outcome Measures

Primary Outcomes (1)

• False negative rate of test for colon cancer

  The False Negative Rate is calculated as (100\*False Negative) /(True Positive + False Negative).

  immediately post surgery

Study Arms (1)

Diagnosed colon cancer patients

Patients undergoing colectomy for colonic adenocarcinoma.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with colonic adenocarcinoma undergoing colectomy at University of Colorado

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Metabiomics Corp: lead

Study Sites (1)

University of Colorado School of Medicine Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

gut microbiome samples from stool, rectal and colonic mucosa

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 26, 2025

Record last verified: 2018-08

Locations

US (1)