Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
|ClinicalTrials.gov Identifier: NCT03951792|
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : May 20, 2020
|Condition or disease|
|Cancer Colon Gastrointestinal Disease|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects|
|Actual Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||June 30, 2026|
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
- DNA/RNA Biomarkers [ Time Frame: 5 years ]Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.
- Microbial 16S rDNA Biomarkers [ Time Frame: 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.
- Protein Measurements [ Time Frame: 5 years ]Based on our initial findings protein measurements may also be performed on any extra residual specimens.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951792
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Nicholas Chia, PhD||Mayo Clinic|