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NCT05112614 Clinical Trial

Role of Gut Microbiome in Cancer Therapy

Malignant Solid Neoplasm Clinical Trial

Official title:
Role of Gut Microbiome in Cancer Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05112614
Other study ID # 19-003060
Secondary ID NCI-2021-10793
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2019
Est. completion date October 1, 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date October 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and stool samples
Other:
• Electronic Health Record Review
Review of medical records

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gut microbiome associations with cancer diagnoses Will be done using Shogun pipeline for metagenomics data followed by analysis using QIIME 2.0. Through study completion, average of 1 year
Primary 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. Through study completion, average of 1 year
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