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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 8 центров

• 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

Италия · 7 центров

• 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

Бельгия · 5 центров

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

Испания · 5 центров

• 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

Франция · 3 центра

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

Нидерланды · 3 центра

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

Великобритания · 3 центра

• 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

Австрия · 2 центра

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

Португалия · 2 центра

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

Швейцария · 2 центра

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

Греция · 1 центр

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

Норвегия · 1 центр

• Oslo University Hospital - Radiumhospitalet — Oslo

Идентификаторы

NCT: NCT05259605 · EORTC-2013-BTG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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