Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03951792

Enrollment

220

Registered

2019-05-15

Start date

2019-05-28

Completion date

2024-03-15

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Colon, Gastrointestinal Disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results