Clinical trial · Interventional
Pediatric Prospective Personalized Immune and Target Identification Trial
Prospective, Interventional Diagnostic, Multicenter, Non-treatment Clinical Study Identifying Specific Molecular Changes by Using Genomic Sequencing Technologies in Refractory/Recurrent or Very High-risk Pediatric CNS Tumors.
NCT04859543CI-TRIAL-00110121PPROSPERITITcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PPROSPERITIT is a prospective clinical study assessing the use of comprehensive molecular profiling to define the best matching targeted and immune treatment for relapsed, refractory or very high risk pediatric CNS tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Neoplasms | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| GEN1 Gene Mutation | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FoundationOneHeme | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Diagnostic group
- description
- Tumor and blood samples will be collected from each patient and broad molecular profiling will be performed. The results of the evaluation of the tumor specimens will determine if the patient's tumor has an actionable mutation for which treatment is available.
- interventionNames
- Device: FoundationOneHeme
Primary outcomes (1)
- measure
- The proportion of patients in which F1Heme molecular testing identified at least 1 clinically relevant alteration at the time of MTB decision.
- timeFrame
- Diagnostic assessment is done within 28 days from enrolment patient in the study.
- description
- Evaluation of the feasibility of FoundationOneHeme
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient Informed consent form must be appropriately obtained under the applicable local and regulatory requirements. Each patient must sign a consent form prior the enrollment to document their willingness to participate. 2. The subject is male or female, aged 1 - 19 years 3. The subject must have a histologically proven recurrent/ refractory or very high-risk CNS tumors 4. Patients must be in good overall physical condition, which allows tumor biopsy 5. Patients must have a life expectancy of at least 3 months. 6. Patients must have a tumor amenable to image-guided or direct vision biopsy and be willing and able to undergo a tumor biopsy and/or blood taking for molecular profiling. 7. Patients must be accessible for follow-up. Exclusion Criteria: 1. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 2. Pregnant and/or breastfeeding women, if applicable 3. No intention to treat the patient.
References
Publications (0)
Data not yet available
No reference posted for this study.