Metabiomics Colon Cancer Clinical Research Study

Colonic Neoplasms Clinical Trial

Official title:

Metabiomics Colon Cancer Clinical Research Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02151123
• Other study ID #: MB-02_CU
• Status: Not yet recruiting
• Start date: March 2019
• Est. completion date: September 2020

Study information

• Verified date: August 2018
• Source: Metabiomics Corp
• Contact: Tracey MacDermott
• Phone: 303-724-2757
• Email: tracey.macdermott[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Metabiomics Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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