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

NCT06323408 | Not Yet Recruiting DMC

• 1 other identifier: BZKF-AYA_1.0
• Study Type: observational
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Glioma, Malignant; Embryonal Tumor; Medulloblastoma; Ependymoma

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  March 2026

• Quality control analysis in radiotherapy

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

  March 2026

• Analysis of response in liquid biopsies

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

  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

  March 2026

• Evaluation of progression free survival

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

  March 2026

Study Arms (2)

Embryonal

Embryonal tumors, including medulloblastoma and ATRT

Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluid

Glioma, IDH-mutated

IDH-mutated gliomas, including WHO grades 2, 3 and 4

Diagnostic Test: Tissue, blood, cerebrospinal-spinal fluid

Interventions

Tissue, blood, cerebrospinal-spinal fluid DIAGNOSTIC_TEST

Processing, analysis

Embryonal; Glioma, IDH-mutated

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Regensburg: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood, cerebrospinal fluid

MeSH Terms

Conditions

Glioma; Neoplasms, Germ Cell and Embryonal; Medulloblastoma; Ependymoma

Interventions

Histocompatibility Testing; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Peter Hau, Prof.

  University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hau, Prof.

CONTACT

+49941944; peter.hau@ukr.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share