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Completed

NCT Number: NCT03951792

Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

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.

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Key information

Conditions

Cancer Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. DNA/RNA Biomarkers

    Time frame: 5 years

    Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.

  2. 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.

Secondary outcomes

  1. Protein Measurements

    Time frame: 5 years

    Based on our initial findings protein measurements may also be performed on any extra residual specimens.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 15, 2019
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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