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RecruitingNCT06117930Updated Feb 5, 2026

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

An observational study in Malignant Central Nervous System Neoplasm, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Malignant Central Nervous System Neoplasm
03

In context

Central Nervous System Neoplasms

673 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's planned enrollment of 100 is close to the median of 108 across 91 observational studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational

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

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-interventional study

06

What researchers measure

Primary outcomes

  1. Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository

    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.

    Time frame: Approximately 1 year, or until samples have been collected based on scheduled treatment.

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06117930
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Feb 28, 2024
Primary completion
Dec 13, 2029 (estimated)
Completion
Dec 13, 2029 (estimated)
Last update
Feb 5, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Alfredo Quinones-Hinojosa, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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