Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification

Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments.

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Ependymoma; Hemangiopericytoma; Diffuse Midline Glioma, H3 K27M-Mutant; Germ Cell Tumor; Embryonal Tumor; Hemangioblastoma; Glioneuronal Tumor; Choroid Plexus Tumor; Pineal Tumors; Tumor of the Sellar Region; Pineal Tumor; Melanocytic Tumor of CNS
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 1650

Contacts and Locations

• Study Contact: Name: EORTC HQ; Phone Number: +32 2 774 1611; Email: eortc@eortc.org

Study Locations

• Austria
  • Innsbruck, Austria
    • Recruiting
    • Innsbruck Universitaetsklinik
  • Vienna, Austria
    • Recruiting
    • Universitaetsklinikum Wien - AKH unikliniken
• Belgium
  • Aalst, Belgium
    • Recruiting
    • Onze Lieve Vrouw Ziekenhuis
  • Anderlecht, Belgium
    • Recruiting
    • Institut Jules Bordet
  • Brussels, Belgium
    • Recruiting
    • Universitair Ziekenhuis Brussel
  • Liège, Belgium
    • Recruiting
    • C.H.U. Sart-Tilman
  • Roeselare, Belgium
    • Recruiting
    • AZ Delta - Campus Rumbeke
• France
  • Lyon, France
    • Recruiting
    • CHU Lyon - Hopital neurologique Pierre Wertheimer
  • Marseille, France
    • Recruiting
    • Hopital De La Timone
  • Paris, France
    • Recruiting
    • Hôpital La Pitié-Salpétrière
• Germany
  • Bochum, Germany, 44892
    • Recruiting
    • Knappschaft Krankenhaus Langendreer
  • Bonn, Germany, 53105
    • Recruiting
    • Universitaetsklinikum Bonn
  • Cologne, Germany, 50937
    • Recruiting
    • Universitaetsklinikum Koeln
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum - Essen
  • Frankfurt, Germany
    • Recruiting
    • University Hospital Frankfurt -Senckenberg Institute of Neurooncology
  • Jena, Germany, 07447
    • Recruiting
    • Universitaetsklinikum Jena
  • Leipzig, Germany
    • Recruiting
    • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
  • Regensburg, Germany
    • Recruiting
    • Universitaetsklinikum Regensburg
• Greece
  • Athens, Greece
    • Recruiting
    • Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
• Italy
  • Bologna, Italy
    • Recruiting
    • Ospedale Bellaria-Bologna
  • Florence, Italy
    • Recruiting
    • Azienda Ospedaliero-Universitaria Careggi
  • Milan, Italy, 20132
    • Recruiting
    • Irccs Ospedale San Raffaele
  • Milan, Italy
    • Recruiting
    • Istituto Neurologico Carlo Besta
  • Padua, Italy
    • Recruiting
    • Istituto Oncologico Veneto
  • Roma, Italy, 00144
    • Recruiting
    • IRCCS-Regina Elena National Cancer Center
  • Torino, Italy
    • Recruiting
    • Ospedale San Giovanni - Dipartimento Neuroscienze
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
  • Leiden, Netherlands
    • Recruiting
    • Leiden University Medical Centre
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital - Radiumhospitalet
• Portugal
  • Lisbon, Portugal
    • Recruiting
    • Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria
  • Lisbon, Portugal
    • Recruiting
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain
    • Recruiting
    • Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
  • L'Hospitalet de Llobregat, Spain
    • Recruiting
    • Hospital Duran i Reynals
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
• Switzerland
  • Lausanne, Switzerland
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois
  • Zurich, Switzerland
    • Recruiting
    • UniversitaetsSpital Zurich - Neurology Clinic
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Recruiting
    • NHS Lothian - The Royal Infirmary Of Edinburgh
  • Newcastle upon Tyne, United Kingdom
    • Recruiting
    • Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care
  • Nottingham, United Kingdom
    • Recruiting
    • Nottingham University Hospitals NHS Trust - City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed or recurrent primary brain tumours, notably those considered to be very rare brain tumours or rare subtypes of common brain tumours will be included. Patients diagnosed between 2011 and 2025.

Description

• Age ≥ legal age of consent
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

17

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"Molecular" Gliobastomas, IDH-wildtype; No intervention	Other: 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;
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
Circumscribed astrocytic gliomas; No intervention
Glioneuronal and neuronal tumours; No intervention
Ependymal tumours; No intervention
Choroid plexus tumours; No intervention
Embryonal tumours; No intervention; medulloblastoma; other
Pineal tumours; No intervention
Meningiomas with specific driver mutations and/or grade 3; No intervention
Mesenchymal, non-meningothelial tumours; No intervention; solitary fibrous tumour hemangioblastomaall all others
Germ cell tumours; No intervention
Primary brain tumour with BRAF mutation; No intervention
Primary brain tumour with NTRK fusion; No intervention
Primary brain tumour with known germline mutation or family history of a primary brain tumour; No intervention
Astrocytoma, IDH-mutant, CNS WHO grade 4.; No intervention
Previously poorly or undefined tumour entities.; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best overall and objective response	Recorded from the date start of an anti-tumor therapy until disease progression or start of a new anti-tumor therapy.	Followed up for 10 years
Progression free survival	From the date of start of the anti-tumor therapy until the date of first objective progression as determined by the local investigator or the date of patient's death whichever occurs first. Patients will be followed up for 5 years after enrolment.	Followed up for 10 years
Overall Survival	Calculated from the date of first pathological diagnosis of the brain tumour; Until the date of death from any cause	Followed up for 10 years
Patient and Disease Characteristics	Eligibility, demographics, comorbidities, molecular data	At enrolment and updated every 6 months during follow-up, up to 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of patient and disease characteristics between 2016 vs 2021 WHO classifications	At enrolment and during follow-up, up to 10 years
Comparison of treatments and outcomes between classifications	From enrolment through follow-up, up to 10 years
Neuroimaging features at diagnosis and progression	At initial diagnosis and at each documented progression, up to 10 years
Generation of reference datasets for future trials	Throughout study duration, up to 10 years

Other Outcome Measures

Outcome Measure	Time Frame
Molecular profiling of tumour entities	At diagnosis and/or progression, up to 10 years (depending on tissue availability)
Characterization of rare/undefined tumours (Cohort 17)	At diagnosis and during follow-up, up to 10 years
Next Intervention-Free Survival (NIFS) - Cohort 16 only	From start of anti-tumour therapy until next intervention or death, up to 10 years

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Principal Investigator: Michael Weller, EORTC Study Coordinator

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 29, 2038

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Gliomas; Rare primary brain tumor; 2021 WHO Classification; molecular diagnosis; Choroid plexus tumors; Embryonal tumors; Pineal tumors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Central Nervous System Neoplasms; Brain Neoplasms; Hemangioma, Capillary; Hemangioma; Cerebral Ventricle Neoplasms; Glioma; Neoplasms, Germ Cell and Embryonal; Ependymoma; Hemangioblastoma; Choroid Plexus Neoplasms; Hemangiopericytoma; Pinealoma; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: EORTC-2013-BTG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No