Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Sponsors

Lead sponsor: Mayo Clinic

Collaborator: National Institutes of Health (NIH)
National Cancer Institute (NCI)

Source Mayo Clinic
Brief Summary

Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

Detailed Description

The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer.

Study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.

Overall Status Enrolling by invitation
Start Date February 15, 2019
Completion Date June 30, 2026
Primary Completion Date December 31, 2025
Study Type Observational
Primary Outcome
Measure Time Frame
DNA/RNA Biomarkers 5 years
Microbial 16S rDNA Biomarkers 5 years
Secondary Outcome
Measure Time Frame
Protein Measurements 5 years
Enrollment 500
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- 18 years of age or older

- Patients undergoing bowel resection by any standard surgical approach.

Exclusion Criteria:

- Female that are pregnant

- Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.

- Currently receiving or have received chemotherapy in the past 2 weeks.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nicholas Chia, PhD Principal Investigator Mayo Clinic
Location
facility Mayo Clinic in Rochester
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mayo Clinic

Investigator full name: Nicholas Chia

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Colorectal Cancer Subjects

Description: Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected

Arm group label: Benign Colon Resection Subjects

Description: Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected

Patient Data No
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov