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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06117930
Enrollment
100
Registered
2023-11-07
Start date
2024-02-28
Completion date
2029-12-13
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Central Nervous System Neoplasm

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Establish the Mayo Clinic Florida Tumor-Gut Axis BiorepositoryApproximately 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.

Countries

United States

Contacts

CONTACTClinical Trials Referral Office
mayocliniccancerstudies@mayo.edu855-776-0015
PRINCIPAL_INVESTIGATORAlfredo Quinones-Hinojosa, M.D.

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026