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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06117930
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Central Nervous System Neoplasm	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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.

3. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research
• Anticipated Study Start Date: Dec 13, 2023
• Anticipated Primary Completion Date: Dec 13, 2028
• Anticipated Study Completion Date: Dec 13, 2028

Arms and Interventions

Arm	Intervention/Treatment
Observational Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.	Other: Non-Interventional Study; Non-interventional study

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Alfredo Quinones-Hinojosa, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06117930
• Other Study ID Numbers: 23-001388; NCI-2023-04797; 23-001388; MC230707
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms

Study Results

No Results Posted as of Nov 7, 2023