跳至主要内容
临床试验/NCT07417085
NCT07417085招募中不适用

Implications and Applications of Microbiota in Pediatric Brain Tumors

Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change in the composition of the microbiota

研究概览

简要总结

In recent years, there has been growing interest in the human gut microbiota, whose health is characterised by high microbial diversity. Through the gut-brain axis, the microbiota influences the homeostasis of the central nervous system by regulating neurological, immune and epigenetic functions. Intestinal dysbiosis is associated with various neurological and oncological diseases, including paediatric diseases and colorectal cancer. Recent studies highlight a significant link between microbiota and brain tumours: cancer patients show reduced microbial richness and altered bacterial composition. In addition, an intratumoural microbial population has been identified that can influence tumour initiation, progression and response to therapies by modulating tumour cells and the immune system. The aim of this study is to analyse stool samples to study the microbiota in children suspected CNS brain tumor as there are currently no studies of this kind reported in the literature to assess whether microbial changes can be detected at diagnosis, can be found during the course of the disease or are associated with tumour progression.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 3 and 18 years with suspected CNS tumour undergoing neurosurgery (intracranial and spinal localisation)
  • Patients who have not undergone prolonged antibiotic or probiotic therapy in the three months prior to sample collection.
  • Signature of informed consent form.

排除标准

  • personal history of chronic inflammatory bowel disease (colitis, Crohn's disease, ulcerative colitis) and congenital or acquired gastrointestinal diseases (coeliac disease, diverticulitis and diverticulosis, peritonitis, Hirschsprung's disease, short bowel syndrome, intestinal malrotation or duplication, intestinal atresia, omphalocele, presence of stomas, acute gastroenteritis)
  • history of previous cancer-related treatments
  • diagnosis of brain tumour not confirmed by histology (data obtainable post-surgery)

研究组 & 干预措施

Patients

Other

Pediatric patients with brain tumors

干预措施: Biological samples (Diagnostic Test)

Controls

Other

Pediatric subjects not affected by brain tumor

干预措施: Fecal samples (Diagnostic Test)

结局指标

主要结局

Change in the composition of the microbiota

时间窗: At enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months

次要结局

未报告次要终点

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iacopo Sardi

Principal Investigator

Meyer Children's Hospital IRCCS

研究点 (1)

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