Role of Gut Microbiome in Cancer Therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05112614

Enrollment

3000

Registered

2021-11-09

Start date

2019-09-11

Completion date

2030-10-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

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.

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood and stool samples

OTHERElectronic Health Record Review

Review of medical records

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 Quantitative Insights Into Microbial Ecology (QIIME) 2.0.
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.

Countries

United States

Contacts

CONTACTClinical Trials Referral Office

mayocliniccancerstudies@mayo.edu855-776-0015

PRINCIPAL_INVESTIGATORPurna C. Kashyap, MBBS

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026