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RecruitingObservational

Role of Gut Microbiome in Cancer Therapy

NCT ID: NCT05112614Sponsor: Mayo ClinicLast updated: 2026-03-16

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.

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.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood and stool samples

  • OtherElectronic Health Record Review

    Review of medical records

Outcome measures

Primary

  • Gut microbiome associations with cancer diagnoses

    Will be done using Shogun pipeline for metagenomics data followed by analysis using Quantitative Insights Into Microbial Ecology (QIIME) 2.0.

    Time frame: Through study completion, average of 1 year

  • Associations between microbial community abundances and clinical outcomes

    Will use a linear multivariate regression model specifically developed for microbiome data (MaAsLin, Multivariate microbial Association by Linear models.

    Time frame: Through study completion, average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy 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

Study locations (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Active Not Recruiting

Mayo Clinic in Florida

Jacksonville, Florida, 32224

Active Not Recruiting

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Purna C. Kashyap, MBBS · Principal Investigator
Role of Gut Microbiome in Cancer Therapy | Cancerify