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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Best overall and objective response [Time frame: Followed up for 10 years]
• Progression free survival [Time frame: Followed up for 10 years]
• Overall Survival [Time frame: Followed up for 10 years]
• Patient and Disease Characteristics [Time frame: At enrolment and updated every 6 months during follow-up, up to 10 years]

Secondary outcome measures (4)

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

Eligibility criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 8 centers

• Knappschaft Krankenhaus Langendreer — Bochum
• Universitaetsklinikum Bonn — Bonn
• Universitaetsklinikum Koeln — Cologne
• Universitaetsklinikum - Essen — Essen
• University Hospital Frankfurt -Senckenberg Institute of Neurooncology — Frankfurt
• Universitaetsklinikum Jena — Jena
• Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie — Leipzig
• Universitaetsklinikum Regensburg — Regensburg

Italy · 7 centers

• Ospedale Bellaria-Bologna — Bologna
• Azienda Ospedaliero-Universitaria Careggi — Florence
• Istituto Neurologico Carlo Besta — Milan
• IRCCS Ospedale San Raffaele — Milan
• Istituto Oncologico Veneto — Padova
• IRCCS-Regina Elena National Cancer Center — Roma
• Ospedale San Giovanni - Dipartimento Neuroscienze — Torino

Belgium · 5 centers

• Onze Lieve Vrouw Ziekenhuis — Aalst
• Institut Jules Bordet — Anderlecht
• Universitair Ziekenhuis Brussel — Brussels
• C.H.U. Sart-Tilman — Liège
• AZ Delta - Campus Rumbeke — Roeselare

Spain · 5 centers

• Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals — L'Hospitalet de Llobregat
• Hospital Clinic de Barcelona — Barcelona
• Hospital De La Santa Creu I Sant Pau — Barcelona
• Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) — Barcelona
• Hospital Duran i Reynals — L'Hospitalet de Llobregat

France · 3 centers

• CHU Lyon - Hopital neurologique Pierre Wertheimer — Lyon
• Hopital de La Timone — Marseille
• Hopital la Pitie-Salpetriere — Paris

Netherlands · 3 centers

• The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis — Amsterdam
• Leiden University Medical Centre — Leiden
• Erasmus MC — Rotterdam

United Kingdom · 3 centers

• NHS Lothian - The Royal Infirmary Of Edinburgh — Edinburgh
• Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care — Newcastle upon Tyne
• Nottingham University Hospitals NHS Trust - City Hospital — Nottingham

Austria · 2 centers

• Innsbruck Universitaetsklinik — Innsbruck
• Universitaetsklinikum Wien - AKH unikliniken — Vienna

Portugal · 2 centers

• Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria — Lisbon
• Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE — Lisbon

Switzerland · 2 centers

• Centre Hospitalier Universitaire Vaudois — Lausanne
• UniversitaetsSpital Zurich - Neurology Clinic — Zurich

Greece · 1 center

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

Norway · 1 center

• Oslo University Hospital - Radiumhospitalet — Oslo

Identifiers

NCT: NCT05259605 · EORTC-2013-BTG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗