MICRO-BRAIN 2024: Study on Pediatric Brain Tumors
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: Biological samples, Fecal samples.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Microbiota. Basic parameters: 3 years — 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
- Italy
- 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
Implications and Applications of Microbiota in Pediatric Brain Tumors
Overview
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.
Interventions
- Diagnostic test Biological samples
Analysis of fungal and bacterial genomic DNA from fecal samples, rectal swabs, and tumor biopsy - Diagnostic test Fecal samples
Analysis of fungal and bacterial genomic DNA from fecal samples
Primary outcome measures
- Change in the composition of the microbiota [Time frame: At enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 1 center
- Meyer Children's Hospital IRCCS — Florence
Identifiers
NCT: NCT07417085 · MICRO-BRAIN 2024