Role of Gut Microbiome in Cancer Therapy

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

• Registration Number: NCT05112614
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2019-09-11
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-09
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2029-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

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Exclusion Criteria

• Unable to provide informed consent
• Vulnerable adults

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen collection, medical record review)	Biospecimen Collection	Patients undergo collection of blood and stool samples and have their medical records reviewed.
Observational (biospecimen collection, medical record review)	Electronic Health Record Review	Patients undergo collection of blood and stool samples and have their medical records reviewed.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States