Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Completed

• Conditions: Gastrointestinal Disease; Cancer Colon

• Registration Number: NCT03951792
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2019-05-28
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DNA/RNA Biomarkers	5 years	Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.
Microbial 16S rDNA Biomarkers	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Protein Measurements	5 years	Based on our initial findings protein measurements may also be performed on any extra residual specimens.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States