Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

NCT03951792 | Completed

• 4 other identifiers: 21-001536R01CA17924318-009965P30CA015083
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Colon; Gastrointestinal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Protein Measurements

  5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years of age or older
• Patients undergoing bowel resection by any standard surgical approach.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Tissue Biopsy

MeSH Terms

Conditions

Colonic Neoplasms; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Nicholas L. Chia, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: May 28, 2019
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)