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Role of Gut Microbiome in Cancer Therapy

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05112614
Collaborator
National Cancer Institute (NCI) (NIH)
5,000
Enrollment
1
Location
72.7
Anticipated Duration (Months)
68.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVE:
  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Gut Microbiome in Cancer Therapy
Actual Study Start Date :
Sep 11, 2019
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Gut microbiome associations with cancer diagnoses [Through study completion, average of 1 year]

      Will be done using Shogun pipeline for metagenomics data followed by analysis using QIIME 2.0.

    2. Associations between microbial community abundances and clinical outcomes [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Purna C Kashyap, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05112614
    Other Study ID Numbers:
    • 19-003060
    • NCI-2021-10793
    • 19-003060
    • P30CA015083
    First Posted:
    Nov 9, 2021
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Nov 9, 2021