Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Malignant Central Nervous System Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research
Overview
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
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository [Time frame: Approximately 1 year, or until samples have been collected based on scheduled treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06117930 · MC230707 · NCI-2023-04797 · 23-001388