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NCT Number: NCT06117930

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

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

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Key information

Conditions

Malignant Central Nervous System Neoplasm Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Alfredo Quinones-Hinojosa, M.D.

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 7, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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