CompletedNot Applicable

Pediatric Prospective Personalized Immune and Target Identification Trial

Austria, Czechia80 participantsStarted 2021-02-02

Plain-language 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.

Who can participate

Age range1 Year – 19 Years

SexALL

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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.

What they're measuring

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.

Trial details

NCT IDNCT04859543

SponsorMasaryk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-10

View on ClinicalTrials.gov More Central Nervous System Neoplasms trials