Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
NCT ID: NCT05259605
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1650 participants
OBSERVATIONAL
2023-03-21
2038-07-29
Brief Summary
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The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.
Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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"Molecular" Gliobastomas, IDH-wildtype
No intervention
Observational
The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.
Paediatric-type diffuse low-grade gliomas
No intervention;
No interventions assigned to this group
Paediatric-type diffuse high-grade gliomas
No intervention;
* diffuse midline glioma, H3 K27-altered
* diffuse hemispheric glioma, H3 G34-mutant
* diffuse paediatric-type high-grade glioma, H3-wildtype and IDH-wildtype
* infant-type hemispheric glioma
No interventions assigned to this group
Circumscribed astrocytic gliomas
No intervention
No interventions assigned to this group
Glioneuronal and neuronal tumours
No intervention
No interventions assigned to this group
Ependymal tumours
No intervention
No interventions assigned to this group
Choroid plexus tumours
No intervention
No interventions assigned to this group
Embryonal tumours
No intervention;
* medulloblastoma
* other
No interventions assigned to this group
Pineal tumours
No intervention
No interventions assigned to this group
Meningiomas with specific driver mutations and/or grade 3
No intervention
No interventions assigned to this group
Mesenchymal, non-meningothelial tumours
No intervention; solitary fibrous tumour hemangioblastomaall all others
No interventions assigned to this group
Germ cell tumours
No intervention
No interventions assigned to this group
Primary brain tumour with BRAF mutation
No intervention
No interventions assigned to this group
Primary brain tumour with NTRK fusion
No intervention
No interventions assigned to this group
Primary brain tumour with known germline mutation or family history of a primary brain tumour
No intervention
No interventions assigned to this group
Astrocytoma, IDH-mutant, CNS WHO grade 4.
No intervention
No interventions assigned to this group
Previously poorly or undefined tumour entities.
No intervention
No interventions assigned to this group
Interventions
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Observational
The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed or recurrent primary brain tumours within one of the 17 cohorts of interest
* Archival tumour tissue from primary tumour available at the site. Representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed. Exception: only tissue from first surgery is allowed for Cohort 16.
* Available MRI/CT scans from primary brain tumour at initial diagnosis
* Patient's consent
Deceased patient:
The clinical data and/or biological material and/or CT/MRI/PET images can be accessed and used if at least one of the following three conditions is met:
* The patient agreed beforehand in his/her lifetime to a further use of his/her data and/or biological material and/or CT/MRI/PET images, or,
* There is consent of a relative to use data and/or biological material and/or CT/MRI/PET images of the deceased patient, or,
* There is a reference to a corresponding legal declaration covering the exemption in case of the impossibility or disproportion of getting access to an informed consent (e.g., causing strain on relatives of deceased patients).
Additionally, in all cases the following three points need to be fulfilled:
* No documentation of previous objection of the patient to the (re-)use of their data, biological material, CT/MR/PET images for research purposes
* A notification to an ethics committee for the re-use of these data, biological material and CT/MRI/PET images
* Any other national requirements are fulfilled, if applicable
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Michael Weller
Role: PRINCIPAL_INVESTIGATOR
EORTC Study Coordinator
Locations
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Innsbruck Universitaetsklinik
Innsbruck, , Austria
Universitaetsklinikum Wien - AKH unikliniken
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Institut Jules Bordet
Anderlecht, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
C.H.U. Sart-Tilman
Liège, , Belgium
AZ Delta - Campus Rumbeke
Roeselare, , Belgium
CHU Lyon - Hopital neurologique Pierre Wertheimer
Lyon, , France
Hopital de La Timone
Marseille, , France
Hopital la Pitie-Salpetriere
Paris, , France
Knappschaft Krankenhaus Langendreer
Bochum, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum - Essen
Essen, , Germany
University Hospital Frankfurt -Senckenberg Institute of Neurooncology
Frankfurt, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
Leipzig, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens, , Greece
Ospedale Bellaria-Bologna
Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Istituto Neurologico Carlo Besta
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Istituto Oncologico Veneto
Padua, , Italy
IRCCS-Regina Elena National Cancer Center
Roma, , Italy
Ospedale San Giovanni - Dipartimento Neuroscienze
Torino, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Oslo University Hospital - Radiumhospitalet
Oslo, , Norway
Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria
Lisbon, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE
Lisbon, , Portugal
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Barcelona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
UniversitaetsSpital Zurich - Neurology Clinic
Zurich, , Switzerland
NHS Lothian - The Royal Infirmary Of Edinburgh
Edinburgh, , United Kingdom
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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EORTC-2013-BTG
Identifier Type: -
Identifier Source: org_study_id