Role of Gut Microbiome in Cancer Therapy

April 3, 2024 updated by: Purna C. Kashyap, MBBS, Mayo Clinic
This study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. The human microbiome affects the way some cancer drugs are metabolized in the human body. Information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.

OUTLINE:

Patients undergo collection of blood and stool samples and have their medical records reviewed.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Purna C. Kashyap, M.B.B.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cancer therapy for any underlying cancer diagnosis and patients undergoing stem cell transplant for any hematological condition

Description

Inclusion Criteria:

  • Age 18-99
  • Diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition

Exclusion Criteria:

  • Unable to provide informed consent
  • Vulnerable adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (biospecimen collection, medical record review)
Patients undergo collection of blood and stool samples and have their medical records reviewed.
Procedure: Biospecimen Collection
Undergo collection of blood and stool samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
Other: Electronic Health Record Review
Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiome associations with cancer diagnoses
Time Frame: Through study completion, average of 1 year
Will be done using Shogun pipeline for metagenomics data followed by analysis using QIIME 2.0.
Through study completion, average of 1 year
Associations between microbial community abundances and clinical outcomes
Time Frame: Through study completion, average of 1 year
Will use a linear multivariate regression model specifically developed for microbiome data (MaAsLin, Multivariate microbial Association by Linear models.
Through study completion, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Purna C. Kashyap, M.B.B.S., Mayo Clinic in Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2019

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-003060
  • NCI-2021-10793 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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