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Trial Title:
Study of Human Brain-Gut Axis and Gut Microbiome in Patients with Brain Lesions - Repository for Neuroscience Research
NCT ID:
NCT06117930
Condition:
Malignant Central Nervous System Neoplasm
Conditions: Official terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Participants undergo blood, tissue, saliva, urine and stool sample collection and
complete questionnaires on study.
Criteria for eligibility:
Study pop:
All patients undergoing resection for a tumor of the central nervous system and
associated controls are eligible to participate in this study.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Alfredo Quinones-Hinojosa, M.D.
Start date:
February 28, 2024
Completion date:
December 13, 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117930
https://www.mayo.edu/research/clinical-trials
