Three-dimensional tumor models and genomic profiling for pediatric brain tumors
Preliminary Study With Biological Samples, Single-center, Non-profit, to Identify Biological Mechanisms and Resistance to Therapies in Three-dimensional Models Derived From Brain Tumors in Pediatric Patients.
This project will use tumor tissue and blood from children aged 3–18 undergoing neurosurgery to build 3D tumor models and run advanced genomic tests to see if they better characterize tumors and help guide personalized treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Florence, Firenze) |
| Trial ID | NCT07417072 on ClinicalTrials.gov |
What this trial studies
The project collects tumor tissue and peripheral blood from treatment‑naive children aged 3–18 at the time of planned neurosurgery. Samples will undergo third‑generation sequencing and comprehensive genomic and epigenetic analyses to identify tumor alterations and germline information. Patient‑derived three‑dimensional tumor models will be generated to study biology and perform preclinical drug response testing. The integrated dataset aims to support personalized therapeutic strategies and improve preclinical evaluation pipelines for pediatric brain tumors.
Who should consider this trial
Good fit: Children aged 3–18 with suspected brain tumors who are treatment‑naive, scheduled for neurosurgery, and whose legal guardians provide informed consent are ideal candidates.
Not a fit: Patients later found to have non‑neoplastic brain conditions, those with insufficient tissue or blood for analysis, or those who received prior systemic anticancer therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reveal actionable genetic alterations and provide personalized preclinical models to help choose more effective therapies for children with brain tumors.
How similar studies have performed: Genomic profiling and patient‑derived 3D models have shown promise in preclinical work and some adult and pediatric cohorts, but fully integrated personalized pipelines for pediatric brain tumors remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 3-18 years with suspected brain tumours undergoing neurosurgery * No previous bone marrow transplants or other haematological procedures that could potentially interfere with germline analysis. * Patients who have not received any systemic anticancer treatment (including chemotherapy, radiotherapy or targeted therapies) prior to enrolment surgery. * Signature of informed consent Exclusion Criteria: * Subsequent histological confirmation of non-neoplastic brain pathology (e.g. malformations, inflammatory lesions, demyelinating processes). * Insufficient quantity or quality of tumour tissue or peripheral blood for the analyses required by the protocol. * Presence of serious clinical conditions, systemic infections or haemodynamic instability that contraindicate the collection of biological samples or inclusion in the study.
Where this trial is running
Florence, Firenze
- Meyer Children's Hospital IRCCS — Florence, Firenze, Italy (Recruiting)
Study contacts
- Study coordinator: Iacopo Sardi
- Email: iacopo.sardi@meyer.it
- Phone: 0555662631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.