Central Nervous System NeoplasmsPPROSPERITITNCT04859543
Pediatric Prospective Personalized Immune and Target Identification Trial
A study testing FoundationOneHeme in people with Central Nervous System Neoplasms and Pediatric Cancer, run by Masaryk University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Central Nervous System Neoplasms, Pediatric Cancer, GEN1 Gene Mutation
- What is being tested?
- FoundationOneHeme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Feb 2021to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Czechia2 sites
University Hospital Brno
Brno, Černopolní 9,, 613 00
Motol University Hospital
Prague, V Úvalu 84,, 150 06
About this study
Official title: 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.
Read the 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.
- Being tested
- FoundationOneHeme
- Keywords
- Pediatric oncology, CNS tumors, Personalized medicine
- Medical subject headings
- Central Nervous System Neoplasms, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOneHemeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic group | Other | 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. Receives: Device: FoundationOneHeme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in which F1Heme molecular testing identified at least 1 clinically relevant alteration at the time of MTB decision.
Evaluation of the feasibility of FoundationOneHeme
Measured: Diagnostic assessment is done within 28 days from enrolment patient in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start2 Feb 2021
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, Roche s.r.o.
- Responsible party
- Sponsor
- Investigators
- Jaroslav Sterba, Prof, MD, Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859543
- Sponsor's protocol ID
- KDO-2019-001
- Acronym
- PPROSPERITIT
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04859543
- Acronym / sponsor ID
- PPROSPERITIT / KDO-2019-001
- Keywords
- Pediatric oncology, CNS tumors, Personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital, Roche s.r.o.
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic group | Other | Device: FoundationOneHemeTumor 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. |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoundationOneHemeTumor 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. | Device | Diagnostic group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaroslav Sterba, Prof, MD principal investigator
Brno University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoundationOneHeme in people with Central Nervous System Neoplasms and Pediatric Cancer, run by Masaryk University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.