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

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

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 Overview

• Status: Recruiting
• Conditions: Glioma; Ependymoma; Hemangiopericytoma; Diffuse Midline Glioma, H3 K27M-Mutant; Germ Cell Tumor; Embryonal Tumor; Hemangioblastoma; Glioneuronal Tumor; Choroid Plexus Tumor; Pineal Tumors; Tumor of the Sellar Region; Pineal Tumor; Melanocytic Tumor of CNS
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Anticipated): 1250

Contacts and Locations

• Study Contact: Name: EORTC HQ; Phone Number: +3227741611; Email: eortc@eortc.org

Study Locations

• Spain
  • Barcelona
    • Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
      • Principal Investigator: Jordi Bruna Escuder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed or recurrent primary brain tumours, notably those considered to be very rare brain tumours or rare subtypes of common brain tumours will be included. Patients diagnosed between 2011 and 2025.

Description

Inclusion Criteria:

• Newly diagnosed or recurrent primary brain tumours, notably those considered rare brain tumours or rare subtypes of common brain tumours.
• 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.
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Inclusion in interventional studies prior and after

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

18

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gliomas, glioneuronal tumors, and neuronal tumors	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.
Choroid plexus tumors	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.
Embryonal tumors	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.
Cranial and paraspinal nerve tumors	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.
Mesenchymal, non-meningothelial tumors	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.
Melanocytic tumors	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.
Germ cell tumors	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.
Tumors of the sellar region	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.
Diffuse midline glioma, H3 K27M-mutant	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.
Diffuse hemispheric glioma, H3 G34-mutant	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.
Gliomas and glioneuronal tumors driven by MAPK pathway alterations	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.
Gliomas with MYB/MBL1 alterations	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.
Ependymoma	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.
Pineal tumors	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.
Meningioma with specific driver mutations	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.
Hemangiopericytoma (Solitary fibrous tumor)	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.
Hemangioblastoma	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.
Genetic tumor syndromes	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Date of surgery that allowed for the first pathological diagnosis up to the date of death (any cause). Patients will be followed up for 5 years after enrolment.	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.
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. Patients will be followed up for 5 years after enrolment.	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Principal Investigator: Michael Weller, EORTC Study Coordinator

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2023
• Primary Completion (Anticipated): August 28, 2026
• Study Completion (Anticipated): December 15, 2026

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Gliomas; Rare primary brain tumor; 2021 WHO Classification; molecular diagnosis; Choroid plexus tumors; Embryonal tumors; Pineal tumors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Connective Tissue; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Hemangioma, Capillary; Cerebral Ventricle Neoplasms; Neoplasms; Glioma; Brain Neoplasms; Ependymoma; Pinealoma; Hemangiopericytoma; Solitary Fibrous Tumors; Hemangioblastoma; Choroid Plexus Neoplasms
• Other Study ID Numbers: EORTC-2013-BTG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No