Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323408
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-01
Brief Title:
Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas
Sponsor:
University Hospital Regensburg
Organization:
University Hospital Regensburg
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BZKF-AYA
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None