Pediatric Prospective Personalized Immune and Target Identification Trial (PPROSPERITIT)

April 23, 2021 updated by: Masaryk University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • University Hospital Brno
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaroslav Sterba, Prof., MD
        • Sub-Investigator:
          • Pavel Tinka, MD
        • Sub-Investigator:
          • Michal Kyr, MD, PhD
      • Prague, Czechia
        • Recruiting
        • Motol University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Zapotocky, MD, PhD
        • Sub-Investigator:
          • David Sumerauer, MD, PhD

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

1 year to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Diagnostic group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients in which F1Heme molecular testing identified at least 1 clinically relevant alteration at the time of MTB decision.
Time Frame: Diagnostic assessment is done within 28 days from enrolment patient in the study.
Evaluation of the feasibility of FoundationOneHeme
Diagnostic assessment is done within 28 days from enrolment patient in the study.

Collaborators and Investigators

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

Sponsor

Masaryk University

Collaborators

Brno University Hospital
Roche s.r.o.

Investigators

  • Principal Investigator: Jaroslav Sterba, Prof, MD, University Hospital Brno

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)

February 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (ACTUAL)

April 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDO-2019-001

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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