Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Observational
Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.
Intervention: Non-Interventional Study (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported