Role of Gut Microbiome in Cancer Therapy

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood and stool samples

Other names: Biological Sample Collection, Biospecimen Collected

Electronic Health Record Review

Other

Review of medical records

Primary outcomes

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 Quantitative Insights Into Microbial Ecology (QIIME) 2.0.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2030
Study completion: 2030
First posted: Nov 9, 2021
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting