Choroid Plexus Tumor, Diffuse Midline Glioma, H3 K27M-Mutant, Embryonal Tumor, Ependymoma, Germ Cell Tumor, Glioma, Glioneuronal Tumor, Hemangioblastoma, Hemangiopericytoma, Melanocytic Tumor of CNS, Pineal Tumor, Pineal Tumors, Tumor of the Sellar Region
Conditions
Keywords
Rare primary brain tumor, 2021 WHO Classification, molecular diagnosis, Gliomas, Choroid plexus tumors, Embryonal tumors, Pineal tumors
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.
Interventions
OTHERObservational
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.
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Followed up for 10 years | Calculated from the date of first pathological diagnosis of the brain tumour; Until the date of death from any cause |
| Progression free survival | Followed up for 10 years | 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. |
| Patient and Disease Characteristics | At enrolment and updated every 6 months during follow-up, up to 10 years | Eligibility, demographics, comorbidities, molecular data |
| Best overall and objective response | Followed up for 10 years | Recorded from the date start of an anti-tumor therapy until disease progression or start of a new anti-tumor therapy. |
Secondary
| Measure | Time frame |
|---|---|
| Neuroimaging features at diagnosis and progression | At initial diagnosis and at each documented progression, up to 10 years |
| Comparison of patient and disease characteristics between 2016 vs 2021 WHO classifications | At enrolment and during follow-up, up to 10 years |
| Comparison of treatments and outcomes between classifications | From enrolment through follow-up, up to 10 years |
| Generation of reference datasets for future trials | Throughout study duration, up to 10 years |
Other
| Measure | Time frame |
|---|---|
| Molecular profiling of tumour entities | At diagnosis and/or progression, up to 10 years (depending on tissue availability) |
| Next Intervention-Free Survival (NIFS) - Cohort 16 only | From start of anti-tumour therapy until next intervention or death, up to 10 years |
| Characterization of rare/undefined tumours (Cohort 17) | At diagnosis and during follow-up, up to 10 years |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Norway, Portugal, Spain, Switzerland, United Kingdom
Contacts
Primary ContactEORTC HQ
Outcome results
None listed