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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	15 Years - 39 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. first diagnosis of high-risk CNS tumors including glioma IDHmutated, medulloblastoma, ependymoma 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. resection, extended biopsy or stereotactic biopsy with sufficient tissue volume. 5. multimodal therapy planned at the discretion of the treating specialist. 6. expected survival time of at least 6 months. 7. informed consent from the patient or the patient's legal guardian prior to the first study procedure. 8. complete material collection expected.

Exclusion Criteria:

1. synchronous independent tumor disease other than basal cell carcinoma and carcinoma in situ. 2. participation in interventional clinical trial except in standard arms of interventional clinical trials.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06323408
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Regensburg
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter Hau, Prof.
Principal Investigator Affiliation	University Hospital Regensburg
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Malignant, Embryonal Tumor, Medulloblastoma, Ependymoma

Additional Details

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.

Arms & Interventions

Arms

: Embryonal

Embryonal tumors, including medulloblastoma and ATRT

: Glioma, IDH-mutated

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

Interventions

Diagnostic Test: - Tissue, blood, cerebrospinal-spinal fluid

Processing, analysis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Peter Hau, Prof.

peter.hau@ukr.de

+49941944

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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