Clinical trial NCT05259605: Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
Official title: Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2022-02-28
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.
Secondary outcomes:
measure: Progression free survival
timeFrame: Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.
measure: Best overall and objective response
timeFrame: Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Vienna
country: Austria
facility: Universitaetsklinikum Wien - AKH unikliniken
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Liège
country: Belgium
facility: C.H.U. Sart-Tilman
city: Roeselare
country: Belgium
facility: AZ Delta - Campus Rumbeke
city: Lyon
country: France
facility: CHU Lyon - Hopital neurologique Pierre Wertheimer
city: Marseille
country: France
facility: Hopital de La Timone
city: Paris
country: France
facility: Hopital la Pitie-Salpetriere
city: Bochum
country: Germany
facility: Knappschaft Krankenhaus Langendreer
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Cologne
country: Germany
facility: Universitaetsklinikum Koeln
city: Essen
country: Germany
facility: Universitaetsklinikum - Essen
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt -Senckenberg Institute of Neurooncology
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Athens
country: Greece
facility: Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
city: Bologna
country: Italy
facility: Ospedale Bellaria-Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milan
country: Italy
facility: Istituto Neurologico Carlo Besta
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Roma
country: Italy
facility: IRCCS-Regina Elena National Cancer Center
city: Torino
country: Italy
facility: Ospedale San Giovanni - Dipartimento Neuroscienze
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Oslo
country: Norway
facility: Oslo University Hospital - Radiumhospitalet
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE
city: Hospitalet De Llobregat
country: Spain
facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: UniversitaetsSpital Zurich - Neurology Clinic
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - The Royal Infirmary Of Edinburgh
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital
Study officials:
affiliation: EORTC Study Coordinator
name: Michael Weller
role: PRINCIPAL_INVESTIGATOR
References: