Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Gastrointestinal Disease Clinical Trial

Official title:

Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951792
• Other study ID #: 21-001536
• Secondary ID: R01CA17924318-00
• Status: Completed
• Start date: May 28, 2019
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Colon
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA/RNA Biomarkers	Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.	5 years
Primary	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	Protein Measurements	Based on our initial findings protein measurements may also be performed on any extra residual specimens.	5 years