Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research

Recruiting

• Conditions: Malignant Central Nervous System Neoplasm
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06117930
• Lead Sponsor: Mayo Clinic

Brief Summary

This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.

Detailed Description

PRIMARY OBJECTIVES:

I. To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.

II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer.

III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy.

OUTLINE: This is an observational study.

Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Study Start: 2024-02-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2029-12-13
• Study Completion: 2029-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.

Exclusion Criteria

• Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Primary Outcome Measures

Name	Time	Method
Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository	Approximately 1 year, or until samples have been collected based on scheduled treatment.	Biological samples such as stool, urine, blood, saliva, and/or tissue will be collected for storage in the Tumor-Gut Axis Biorepository. Samples may be collected at any of the following time periods during study participation: before/after steroid therapy, before/after surgical intervention, before/after radiation therapy, and before/after chemotherapy.

Trial Locations

Locations (1)

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