Glioma, MalignantBZKF-AYANCT06323408
Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas
An observational study of Glioma, Malignant and Embryonal Tumor, run by University Hospital Regensburg.
Trial summary
The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Glioma, Malignant, Embryonal Tumor, Medulloblastoma
- What is being tested?
- Tissue, blood, cerebrospinal-spinal fluid
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 39 years
- All sexes
- Child, Adult
Study population: A total of 72 patients with complete data and biomaterial collection will be recruited into the study, including 36 patients with glioma IDHmutated and 36 patients with pediatric primary intra-axial brain tumors (medulloblastoma, ependymoma, ATRT, others).
Who may be able to join
- first diagnosis of high-risk CNS tumors including glioma IDHmutated, medulloblastoma, ependymoma and other intra-axial primary brain tumors
- adolescents and young adults (AYA; 15 to 39 years)
- Karnofsky status of 60 or higher
- resection, extended biopsy or stereotactic biopsy with sufficient tissue volume
- multimodal therapy planned at the discretion of the treating specialist
- expected survival time of at least 6 months
- informed consent from the patient or the patient's legal guardian prior to the first study procedure
- complete material collection expected.
Who cannot join
- synchronous independent tumor disease other than basal cell carcinoma and carcinoma in situ
- participation in interventional clinical trial except in standard arms of interventional clinical trials.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Collection of Clinical and Imaging Data, Radiotherapy Planning and Biomaterials for Integrated Analysis of Therapy Response and Resistance and Detection of Molecular Targets in Adolescents and Young Adults With CNS Tumors
The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape.
Read the detailed description
Objectives: We are conducting a non-interventional study for AYAs with malignant intraaxial CNS parenchymal tumors. All 6 Bavarian BZKF sites are involved in the study. We will collect data on diagnostic and prognostic MRI and FET-PET imaging, quality assurance in radiotherapy and radiotherapy treatment patterns, diagnostic and predictive liquid biopsies from CSF and blood and targeted therapy approaches and integrate them bioinformatically with clinical data.
Work packages: WP01 Prediction of diagnosis by artificial intelligence (AI)-assisted processing of MRI and FET-PET; WP02 Analysis of response and relapse patterns by AI-assisted processing of MRI and FET-PET; WP03 Quality control of radiotherapy planning and patterns-of-care analysis; WP04 Prediction of response, relapse and treatment density using markers identified in liquid biopsies from CSF and blood; WP05 Identification of targets for targeted therapy from paraffin-embedded tissue (FFPE), CSF and blood; WP06 Investigation of clinical patterns and progression (PFS) or WP07 Bioinformatic integration of data to predict PFS, OS and patterns of response, relapse, treatment density and potential molecular targets.
Inclusion criteria: (1) first diagnosis of high-risk CNS tumors including IDHmutated gliomas, medulloblastomas, ependymomas, and other intra-axial primary brain tumors; (2) adolescents and young adults (AYA; 15 to 39 years); (3) Karnofsky status of 60 or higher; (4) multimodality therapy planned at the discretion of the medical professional; (5) expected survival min. 6 months; (6) informed consent by patient and (for patients under 18 years) legal representative; (7) complete material collection expected.
Exclusion criteria: (1) synchronous independent tumor disease, except basal cell carcinoma and carcinoma in situ; (2) participation in interventional clinical trial, except in standard arms of interventional clinical trials.
- Conditions
- Glioma, Malignant, Embryonal Tumor, Medulloblastoma, Ependymoma
- Being tested
- Tissue, blood, cerebrospinal-spinal fluid
- Medical subject headings
- Glioma, Neoplasms, Germ Cell and Embryonal, Medulloblastoma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue, blood, cerebrospinal-spinal fluidDiagnostic test
Processing, analysis
| Study group | Role | What they receive |
|---|---|---|
| Embryonal | Embryonal tumors, including medulloblastoma and ATRT Receives: Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluid | |
| Glioma, IDH-mutated | IDH-mutated gliomas, including WHO grades 2, 3 and 4 Receives: Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI processing of MRI fand PET or diagnosis
Prediction of diagnosis by artificial intelligence (AI)-assisted processing of magnetic resonance imaging (MRI) and Fluorethyltyrosin-Positron Emission Tomography (FET-PET)
Measured: March 2026
AI processing of MRI and PET for evaluation of response and relapse
Analysis of response and relapse patterns by artificial intelligence (AI)-assisted processing of magnetic resonance imaging (MRI) and Fluorethyltyrosin-Positron Emission Tomography (FET-PET)
Measured: March 2026
Quality control analysis in radiotherapy
Quality control of radiotherapy planning and patterns-of-care analysis
Measured: March 2026
Analysis of response in liquid biopsies
Prediction of response using markers detected in liquid biopsies from cerebrospinal fluid and blood
Measured: March 2026
Target molecules in tissue and liquid biopsies
Identification of target molecules for targeted therapy from paraffin-embedded tissue (FFPE), cerebrospinal fluid and blood
Measured: March 2026
Evaluation of progression free survival
Investigation of clinical patterns of response in view of progression free survival (PFS)
Measured: March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hau, University Hospital Regensburg
- Investigators
- Peter Hau, Prof., Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323408
- Sponsor's protocol ID
- BZKF-AYA_1.0
- Acronym
- BZKF-AYA
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Internal analysis in BZKF network
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Clinical and Imaging Data, Radiotherapy Planning and Biomaterials for Integrated Analysis of Therapy Response and Resistance and Detection of Molecular Targets in Adolescents and Young Adults With CNS Tumors
- ClinicalTrials.gov ID
- NCT06323408
- Acronym / sponsor ID
- BZKF-AYA / BZKF-AYA_1.0
- Conditions
- Glioma, Malignant, Embryonal Tumor, Medulloblastoma, Ependymoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Mar 2024 (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.
The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape.
Detailed description
Objectives: We are conducting a non-interventional study for AYAs with malignant intraaxial CNS parenchymal tumors. All 6 Bavarian BZKF sites are involved in the study. We will collect data on diagnostic and prognostic MRI and FET-PET imaging, quality assurance in radiotherapy and radiotherapy treatment patterns, diagnostic and predictive liquid biopsies from CSF and blood and targeted therapy approaches and integrate them bioinformatically with clinical data.
Work packages: WP01 Prediction of diagnosis by artificial intelligence (AI)-assisted processing of MRI and FET-PET; WP02 Analysis of response and relapse patterns by AI-assisted processing of MRI and FET-PET; WP03 Quality control of radiotherapy planning and patterns-of-care analysis; WP04 Prediction of response, relapse and treatment density using markers identified in liquid biopsies from CSF and blood; WP05 Identification of targets for targeted therapy from paraffin-embedded tissue (FFPE), CSF and blood; WP06 Investigation of clinical patterns and progression (PFS) or WP07 Bioinformatic integration of data to predict PFS, OS and patterns of response, relapse, treatment density and potential molecular targets.
Inclusion criteria: (1) first diagnosis of high-risk CNS tumors including IDHmutated gliomas, medulloblastomas, ependymomas, and other intra-axial primary brain tumors; (2) adolescents and young adults (AYA; 15 to 39 years); (3) Karnofsky status of 60 or higher; (4) multimodality therapy planned at the discretion of the medical professional; (5) expected survival min. 6 months; (6) informed consent by patient and (for patients under 18 years) legal representative; (7) complete material collection expected.
Exclusion criteria: (1) synchronous independent tumor disease, except basal cell carcinoma and carcinoma in situ; (2) participation in interventional clinical trial, except in standard arms of interventional clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embryonal | – | Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluidEmbryonal tumors, including medulloblastoma and ATRT |
| Glioma, IDH-mutated | – | Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluidIDH-mutated gliomas, including WHO grades 2, 3 and 4 |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 72 patients with complete data and biomaterial collection will be recruited into the study, including 36 patients with glioma IDHmutated and 36 patients with pediatric primary intra-axial brain tumors (medulloblastoma, ependymoma, ATRT, others).
Key inclusion criteria (8 listed)
- first diagnosis of high-risk CNS tumors including glioma IDHmutated, medulloblastoma, ependymoma and other intra-axial primary brain tumors
- adolescents and young adults (AYA; 15 to 39 years)
- Karnofsky status of 60 or higher
- resection, extended biopsy or stereotactic biopsy with sufficient tissue volume
- multimodal therapy planned at the discretion of the treating specialist
Key exclusion criteria (2 listed)
- synchronous independent tumor disease other than basal cell carcinoma and carcinoma in situ
- participation in interventional clinical trial except in standard arms of interventional clinical trials.
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 |
|---|---|---|
| Tissue, blood, cerebrospinal-spinal fluidProcessing, analysis | Diagnostic test | Embryonal, Glioma, IDH-mutated |
Primary outcome
AI processing of MRI fand PET or diagnosis
Time frame: March 2026
Prediction of diagnosis by artificial intelligence (AI)-assisted processing of magnetic resonance imaging (MRI) and Fluorethyltyrosin-Positron Emission Tomography (FET-PET)
AI processing of MRI and PET for evaluation of response and relapse
Time frame: March 2026
Analysis of response and relapse patterns by artificial intelligence (AI)-assisted processing of magnetic resonance imaging (MRI) and Fluorethyltyrosin-Positron Emission Tomography (FET-PET)
Quality control analysis in radiotherapy
Time frame: March 2026
Quality control of radiotherapy planning and patterns-of-care analysis
Analysis of response in liquid biopsies
Time frame: March 2026
Prediction of response using markers detected in liquid biopsies from cerebrospinal fluid and blood
Target molecules in tissue and liquid biopsies
Time frame: March 2026
Identification of target molecules for targeted therapy from paraffin-embedded tissue (FFPE), cerebrospinal fluid and blood
Evaluation of progression free survival
Time frame: March 2026
Investigation of clinical patterns of response in view of progression free survival (PFS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. Internal analysis in BZKF network
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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.
Peter Hau, Prof. principal investigator
University Hospital Regensburg
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant and Embryonal Tumor, run by University Hospital Regensburg.
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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hau, Prof. (+49941944 ext. 18740, peter.hau@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AI processing of MRI fand PET or diagnosis (time frame: March 2026). The study lists 6 primary outcomes in all. 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 25 Mar 2025.