Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Disease; Cancer Colon

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jennifer A Martin; Phone Number: (507) 266-6404; Email: martin.jennifer2@mayo.edu
• Study Contact Backup: Name: Kimberly R Krull; Phone Number: (507) 293-3905; Email: krull.kimberly@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Jennifer A Martin; Phone Number: 507-266-6404; Email: martin.jennifer2@mayo.edu
      • Contact: Kimberly R Krull; Phone Number: (507) 293-6746; Email: krull.kimberly@mayo.edu
      • Principal Investigator: Nicholas Chia, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Colorectal Cancer Subjects; Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected
Benign Colon Resection Subjects; Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA/RNA Biomarkers	Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.	5 years
Microbial 16S rDNA Biomarkers	The samples will be used to partially (V3-V5 region) amplify the microbial 16S rDNA genes through a polymerase chain reaction (PCR). The PCR product will subsequently be purified and quantified before being sequenced. They will also be used for whole genome sequencing (WGS) and Methylation sequencing (Methyl-Seq). The RNA will be used for RNAseq.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Measurements	Based on our initial findings protein measurements may also be performed on any extra residual specimens.	5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Nicholas Chia, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 21-001536; 18-009965 (Other Identifier: Mayo Clinic in Rohester); R01CA179243 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No