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临床试验/NCT06117930
NCT06117930
招募中
不适用

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

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 100 人2024年2月28日

概览

阶段
不适用
干预措施
Non-Interventional Study
疾病 / 适应症
Malignant Central Nervous System Neoplasm
发起方
Mayo Clinic
入组人数
100
试验地点
2
主要终点
Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository
状态
招募中
最后更新
2个月前

概览

简要总结

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

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年2月28日
结束日期
2029年12月13日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

发起方
Mayo Clinic
责任方
Sponsor

入排标准

入选标准

  • All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.

排除标准

  • Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.

研究组 & 干预措施

Observational

Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

干预措施: Non-Interventional Study

结局指标

主要结局

Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository

时间窗: 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.

研究点 (2)

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