Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-39
SponsorUniversity Hospital Regensburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tissue, blood, cerebrospinal-spinal fluid
Diagnostic testProcessing, analysis
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Embryonal1 intervention
Group B: Glioma, IDH-mutated1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
March 20262
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)
Time frame
March 20263
Quality control analysis in radiotherapy
Quality control of radiotherapy planning and patterns-of-care analysis
Time frame
March 20264
Analysis of response in liquid biopsies
Prediction of response using markers detected in liquid biopsies from cerebrospinal fluid and blood
Time frame
March 2026Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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