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

NCT06117930 | Recruiting

• 3 other identifiers: MC230707NCI-2023-0479723-001388
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Central Nervous System Neoplasm

Outcome Measures

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.

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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Samples stored for future research if participant gives permission.

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Alfredo Quinones-Hinojosa, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): December 13, 2029
• Study Completion (Estimated): December 13, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)