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 (EORTC)

Status: Enrolling

Conditions: Embryonal Tumor; Melanocytic Tumor of CNS; Pineal Tumors; Germ Cell Tumor; Choroid Plexus Tumor; Glioma; Hemangioblastoma; Glioneuronal Tumor; Pineal Tumor; Tumor of the Sellar Region; Hemangiopericytoma; Ependymoma; Diffuse Midline Glioma, H3 K27M-Mutant

Treatments: Other: Observational

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05259605

EORTC-2013-BTG

Details and patient eligibility

About

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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,650 participants in 17 patient groups

"Molecular" Gliobastomas, IDH-wildtype

Description:

No intervention

Treatment:

Other: Observational

Paediatric-type diffuse low-grade gliomas

Description:

No intervention;

Paediatric-type diffuse high-grade gliomas

Description:

No intervention; * diffuse midline glioma, H3 K27-altered * diffuse hemispheric glioma, H3 G34-mutant * diffuse paediatric-type high-grade glioma, H3-wildtype and IDH-wildtype * infant-type hemispheric glioma

Circumscribed astrocytic gliomas

Description:

No intervention

Glioneuronal and neuronal tumours

Description:

No intervention

Ependymal tumours

Description:

No intervention

Choroid plexus tumours

Description:

No intervention

Embryonal tumours

Description:

No intervention; * medulloblastoma * other

Pineal tumours

Description:

No intervention

Meningiomas with specific driver mutations and/or grade 3

Description:

No intervention

Mesenchymal, non-meningothelial tumours

Description:

No intervention; solitary fibrous tumour hemangioblastomaall all others

Germ cell tumours

Description:

No intervention

Primary brain tumour with BRAF mutation

Description:

No intervention

Primary brain tumour with NTRK fusion

Description:

No intervention

Primary brain tumour with known germline mutation or family history of a primary brain tumour

Description:

No intervention

Astrocytoma, IDH-mutant, CNS WHO grade 4.

Description:

No intervention

Previously poorly or undefined tumour entities.

Description:

No intervention