GenoDrugP 2025: Study on Three-dimensional Models Derived From Brain Tumors in Pediatric Patients

February 10, 2026 updated by: Iacopo Sardi, Meyer Children's Hospital IRCCS

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.

Central nervous system tumours are the most common solid tumours and the leading cause of cancer mortality in children, with high biological and prognostic heterogeneity. Despite advances in the 2021 WHO molecular classifications, treatment options remain limited and often ineffective in high-grade tumours. New third-generation sequencing technologies and three-dimensional models derived from patient tumours offer promising tools for more comprehensive genomic characterisation and preclinical evaluation of drug responses. However, the lack of integrated preclinical studies remains a limitation, necessitating coordinated projects to develop personalised therapeutic strategies. The study aims to investigate the genetic and biological characteristics of paediatric brain tumours. To this end, tumour tissue samples taken during planned surgery and peripheral blood samples will be analysed. Advanced genetic analyses will be performed on these materials to identify tumour alterations and the patient's genetic characteristics. In addition, experimental in vitro models derived from the tumour will be developed to evaluate the response to different chemotherapy drugs. The information obtained will be used to better understand the mechanisms of tumour growth and resistance and to promote the future development of more targeted and personalised therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Firenze
      • Florence, Firenze, Italy
        • Recruiting
        • Meyer Children's Hospital IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric patients with brain tumors
Diagnostic test: Genomic DNA analysis of biological samples
Analysis of genomic DNA from tumor biopsy and blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Single Nucleotide Variants (SNV)
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
Number of SNVs germline in DNA from tumor and blood samples
At enrollment and on the date of first documented progression assessed up to 12 months
Number of copy number variations (CNVs)
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
Number of copy number variations (CNVs) in DNA from tumor and blood samples
At enrollment and on the date of first documented progression assessed up to 12 months
Number of triplet expansions
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
Number of triplet expansions in DNA from tumor and blood samples
At enrollment and on the date of first documented progression assessed up to 12 months
Number of structural variants (SVs)
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
Number of structural variants (SVs) in DNA from tumor and blood sample
At enrollment and on the date of first documented progression assessed up to 12 months
Morphological description of three-dimensional models derived from the tumour
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
At enrollment and on the date of first documented progression assessed up to 12 months
Vitality of three-dimensional models derived from the tumour
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
At enrollment and on the date of first documented progression assessed up to 12 months
Proliferative activity of three-dimensional models derived from the tumour
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
At enrollment and on the date of first documented progression assessed up to 12 months
Percentage of residual cell vitality after drug treatment
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
At enrollment and on the date of first documented progression assessed up to 12 months
Dose-response curves for each drug tested
Time Frame: At enrollment and on the date of first documented progression assessed up to 12 months
Ex vivo chemosensitivity study on three-dimensional models derived from primary tumour cells
At enrollment and on the date of first documented progression assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GenoDrugP 2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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