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

Recruiting

• Conditions: Embryonal Tumor; Glioma; Choroid Plexus Tumor; Tumor of the Sellar Region; Pineal Tumor; Melanocytic Tumor of CNS; Pineal Tumors; Hemangiopericytoma; Glioneuronal Tumor; Germ Cell Tumor
• Interventions: Other: Observational

• Registration Number: NCT05259605
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2023-03-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-08-28
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• Newly diagnosed or recurrent primary brain tumours, notably those considered rare brain tumours or rare subtypes of common brain tumours.
• 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.
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Inclusion in interventional studies prior and after

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Embryonal tumors	Observational	-
Melanocytic tumors	Observational	-
Cranial and paraspinal nerve tumors	Observational	-
Germ cell tumors	Observational	-
Gliomas with MYB/MBL1 alterations	Observational	-
Pineal tumors	Observational	-
Hemangiopericytoma (Solitary fibrous tumor)	Observational	-
Genetic tumor syndromes	Observational	-
Gliomas, glioneuronal tumors, and neuronal tumors	Observational	-
Tumors of the sellar region	Observational	-
Ependymoma	Observational	-
Hemangioblastoma	Observational	-
Mesenchymal, non-meningothelial tumors	Observational	-
Choroid plexus tumors	Observational	-
Diffuse midline glioma, H3 K27M-mutant	Observational	-
Diffuse hemispheric glioma, H3 G34-mutant	Observational	-
Gliomas and glioneuronal tumors driven by MAPK pathway alterations	Observational	-
Meningioma with specific driver mutations	Observational	-

Primary Outcome Measures

Name	Time	Method
Overall survival	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	Date of surgery that allowed for the first pathological diagnosis up to the date of death (any cause). Patients will be followed up for 5 years after enrolment.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	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.
Best overall and objective response	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	Recorded from the date start of an anti-tumor therapy until disease progression or start of a new anti-tumor therapy. Patients will be followed up for 5 years after enrolment.

Trial Locations

Locations (41)

Universitaetsklinikum Bonn; 🇩🇪 Bonn, Germany

NHS Lothian - The Royal Infirmary Of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

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 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; 🇮🇹 Firenze, Italy

Istituto Neurologico Carlo Besta; 🇮🇹 Milan, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, 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; 🇵🇹 Lisboa, Portugal

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE; 🇵🇹 Lisboa, Portugal

Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals; 🇪🇸 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; 🇪🇸 Hospitalet de Llobregat, Spain

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

UniversitaetsSpital Zurich - Neurology Clinic; 🇨🇭 Zürich, Switzerland

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