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

European Organisation for Research and Treatment of Cancer - EORTC1,650 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,650

Conditions

Glioma Glioneuronal Tumor Choroid Plexus Tumor Pineal Tumors Germ Cell Tumor Tumor of the Sellar Region

Interventions

ObservationalOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Followed up for 10 years

Patient and Disease Characteristics

Eligibility, demographics, comorbidities, molecular data

Time frame: At enrolment and updated every 6 months during follow-up, up to 10 years

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (42)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts