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Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03951792
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicholas Chia, Mayo Clinic

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.

Condition or disease
Cancer Colon Gastrointestinal Disease

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. 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
Tissue Biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951792


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nicholas Chia, PhD Mayo Clinic

Additional Information:
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Responsible Party: Nicholas Chia, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03951792     History of Changes
Other Study ID Numbers: 18-009965
R01CA179243 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases