Metabiomics Colon Cancer Clinical Research Study
- Conditions
- Colonic Neoplasms
- Registration Number
- NCT02151123
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method False negative rate of test for colon cancer immediately post surgery The False Negative Rate is calculated as (100\*False Negative) /(True Positive + False Negative).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado School of Medicine Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States