NCT04859543

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Masaryk University · Academic / Other
• Sex: All
• Age: 1 Year – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PPROSPERITIT will identify specific molecular changes by using genomic sequencing technologies in refractory/recurrent or very high-risk pediatric CNS tumors. The study will employ an analytically validated comparison of a selection of targeted agents/immune therapies on the basis of commercially available comprehensive genomic profiling FoundationOneHeme panel (F1Heme, comprising DNA and RNA analysis) vs selection of agents based on more complex DNA/RNA/Protein based analyses. This will be coupled to a computer algorithm that uses preexisting definitions and prioritization of target-agent pairs to assign patients by actionable mutation results to a targeted treatment. The selection of targeted agents will be performed by a multidisciplinary molecular tumor board, but the recommended treatment will not be a part of the PPROSPERTIT study.

Conditions

• Central Nervous System Neoplasms
• Pediatric Cancer
• GEN1 Gene Mutation
• Tumor, Brain

Interventions

Type	Name	Description
DEVICE	FoundationOneHeme	Tumor tissue obtained during standard surgery will be subsequently examined histopathologically and the content of cancer cells will be determined. Broad molecular profiling of the tumor; with potential results finding such molecular changes, for which the specific targeted anti-tumor treatment will be performed.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-31
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

2 sites across 1 country: Czechia