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

NCT05259605 | Recruiting

• 1 other identifier: EORTC-2013-BTG
• Study Type: observational
• Target: 1,650
• Locations: 12 countries
• Sites: 42

Brief Summary

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.

Conditions

Glioma; Glioneuronal Tumor; Choroid Plexus Tumor; Pineal Tumors; Germ Cell Tumor; Tumor of the Sellar Region; Diffuse Midline Glioma, H3 K27M-Mutant; Ependymoma; Embryonal Tumor; Pineal Tumor; Hemangiopericytoma; Hemangioblastoma; Melanocytic Tumor of CNS

Keywords

Rare primary brain tumor; 2021 WHO Classification; molecular diagnosis; Gliomas; Choroid plexus tumors; Embryonal tumors; Pineal tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (17)

"Molecular" Gliobastomas, IDH-wildtype

No intervention

Other: Observational

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

Interventions

Observational OTHER

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.

"Molecular" Gliobastomas, IDH-wildtype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (42)

Innsbruck Universitaetsklinik

Innsbruck, Austria

RECRUITING

Universitaetsklinikum Wien - AKH unikliniken

Vienna, Austria

RECRUITING

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

RECRUITING

Institut Jules Bordet

Anderlecht, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Belgium

RECRUITING

C.H.U. Sart-Tilman

Liège, Belgium

RECRUITING

AZ Delta - Campus Rumbeke

Roeselare, Belgium

RECRUITING

CHU Lyon - Hopital neurologique Pierre Wertheimer

Lyon, France

RECRUITING

Hopital de La Timone

Marseille, France

RECRUITING

Hopital la Pitie-Salpetriere

Paris, France

RECRUITING

Knappschaft Krankenhaus Langendreer

Bochum, 44892, Germany

RECRUITING

Universitaetsklinikum Bonn

Bonn, 53105, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum - Essen

Essen, 45147, Germany

RECRUITING

University Hospital Frankfurt -Senckenberg Institute of Neurooncology

Frankfurt, Germany

RECRUITING

Universitaetsklinikum Jena

Jena, 07447, Germany

RECRUITING

Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie

Leipzig, Germany

RECRUITING

Universitaetsklinikum Regensburg

Regensburg, Germany

RECRUITING

Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.

Athens, Greece

RECRUITING

Ospedale Bellaria-Bologna

Bologna, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

RECRUITING

Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, Italy

RECRUITING

IRCCS-Regina Elena National Cancer Center

Roma, 00144, Italy

RECRUITING

Ospedale San Giovanni - Dipartimento Neuroscienze

Torino, Italy

RECRUITING

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

RECRUITING

Leiden University Medical Centre

Leiden, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Oslo University Hospital - Radiumhospitalet

Oslo, Norway

RECRUITING

Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria

Lisbon, Portugal

RECRUITING

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE

Lisbon, Portugal

RECRUITING

Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, 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)

Barcelona, Spain

RECRUITING

Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

RECRUITING

UniversitaetsSpital Zurich - Neurology Clinic

Zurich, Switzerland

RECRUITING

NHS Lothian - The Royal Infirmary Of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

Newcastle upon Tyne, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Tumour tissue specifically stored for the purpose of this project * Residual biological material ("leftovers") and/or derivatives

MeSH Terms

Conditions

Glioma; Choroid Plexus Neoplasms; Pinealoma; Neoplasms, Germ Cell and Embryonal; Ependymoma; Hemangiopericytoma; Hemangioblastoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebral Ventricle Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Hemangioma

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Michael Weller

  EORTC Study Coordinator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EORTC HQ

CONTACT

+32 2 774 1611; eortc@eortc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 28, 2022
• Study Start: March 21, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 29, 2038
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

BE (5); ES (5); GB (3); DE (8); GR (1); NO (1); CH (2); AU (2); PT (2); NL (3); FR (3); IT (7)