Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Mayo Clinic

Status: Completed

Conditions: Gastrointestinal Disease; Cancer Colon

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03951792

P30CA015083 (U.S. NIH Grant/Contract)

18-009965

R01CA179243 (U.S. NIH Grant/Contract)

21-001536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 2 patient groups

Colorectal Cancer Subjects

Description:

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

Benign Colon Resection Subjects

Description:

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