Metabiomics Colon Cancer Clinical Research Study

NCT ID: NCT02151123

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Colonic Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diagnosed colon cancer patients

Patients undergoing colectomy for colonic adenocarcinoma.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metabiomics Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Vogel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine Anschutz Medical Campus

Christopher Lieu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine Anschutz Medical Campus

Patrick Gillevet, PhD

Role: PRINCIPAL_INVESTIGATOR

George Mason University

Locations

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University of Colorado School of Medicine Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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MB-02_CU

Identifier Type: -

Identifier Source: org_study_id

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