Colonic Neoplasms
Conditions
Keywords
Colonic Neoplasms, Colon Cancer, Microbiome
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.
Interventions
None listed
Sponsors
Metabiomics Corp
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed