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NCT Number: NCT06323408

Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tissue, blood, cerebrospinal-spinal fluid

Diagnostic Test

Processing, analysis

Primary outcomes

  1. 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)

  2. 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)

  3. Quality control analysis in radiotherapy

    Time frame: March 2026

    Quality control of radiotherapy planning and patterns-of-care analysis

  4. Analysis of response in liquid biopsies

    Time frame: March 2026

    Prediction of response using markers detected in liquid biopsies from cerebrospinal fluid and blood

  5. 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

  6. Evaluation of progression free survival

    Time frame: March 2026

    Investigation of clinical patterns of response in view of progression free survival (PFS)

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Hau, Prof.

CONTACT

[email protected]

+49941944 ext. 18740

Sponsors and collaborators

Lead sponsor

University Hospital Regensburg

Other

Registry information

Official study 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

Acronym: BZKF-AYA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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