Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117930
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-10-31
Brief Title:
Study of Human Brain-Gut Axis and Gut Microbiome in Patients with Brain Lesions - Repository for Neuroscience Research
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Study of Human Brain-Gut Axis and Gut Microbiome in Patients with Brain Lesions - Repository for Neuroscience Research
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor tissue samples and clinical patient information
II To use spatial transcriptomeproteomicsmulti-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 andor microbiome reconstruction to impact patients clinical outcomes including chemo radiation immunotherapy andor cellular therapy
OUTLINE This is an observational study
Participants undergo blood tissue saliva urine and stool sample collection and complete questionnaires on study
I To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal urine blood saliva andor tissue samples and clinical patient information
II To use spatial transcriptomeproteomicsmulti-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 andor microbiome reconstruction to impact patients clinical outcomes including chemo radiation immunotherapy andor cellular therapy
OUTLINE This is an observational study
Participants undergo blood tissue saliva urine and stool sample collection and complete questionnaires on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04797 | REGISTRY | None | None |
| 23-001388 | OTHER | Mayo Clinic Institutional Review Board | None |