Metabiomics Colon Cancer Clinical Research Study

Metabiomics Corp

Overview

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

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

Conditions

Colonic Neoplasms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado School of Medicine Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

False negative rate of test for colon cancer

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

Time frame: immediately post surgery

Data from ClinicalTrials.gov

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