Pediatric Prospective Personalized Immune and Target Identification Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    80
  • sponsor
    Masaryk University
Updated on 7 May 2021

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.

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.

Details
Condition Central Nervous System Neoplasms, Malignant neoplasm of brain, Brain Tumor (Pediatric), Pediatric Cancer, Childhood Cancer, Brain Cancer, Brain Tumor, GEN1 Gene Mutation, cns tumors, cns tumor, cns neoplasm, central nervous system tumors, central nervous system tumor
Treatment FoundationOneHeme
Clinical Study IdentifierNCT04859543
SponsorMasaryk University
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
The subject is male or female, aged 1 - 19 years
The subject must have a histologically proven recurrent/ refractory or very high-risk CNS tumors
Patients must be in good overall physical condition, which allows tumor biopsy
Patients must have a life expectancy of at least 3 months
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
Patients must be accessible for follow-up

Exclusion Criteria

Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Pregnant and/or breastfeeding women, if applicable
No intention to treat the patient
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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