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

Recruiting

• Conditions: Embryonal Tumor; Glioma; Choroid Plexus Tumor; Tumor of the Sellar Region; Pineal Tumor; Melanocytic Tumor of CNS; Pineal Tumors; Hemangiopericytoma; Glioneuronal Tumor; Germ Cell Tumor

• Registration Number: NCT05259605
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2023-03-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-08-28
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	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.
Best overall and objective response	Last patient is expect in 2025 and will be followed up for 5 years, the analysis will take place in 2030.	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.

Trial Locations

Locations (41)

Universitaetsklinikum Bonn; 🇩🇪 Bonn, Germany

NHS Lothian - The Royal Infirmary Of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Universitaetsklinikum Wien - AKH unikliniken; 🇦🇹 Vienna, Austria

Onze Lieve Vrouw Ziekenhuis; 🇧🇪 Aalst, Belgium

Institut Jules Bordet; 🇧🇪 Anderlecht, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

C.H.U. Sart-Tilman; 🇧🇪 Liège, Belgium

AZ Delta - Campus Rumbeke; 🇧🇪 Roeselare, Belgium

CHU Lyon - Hopital neurologique Pierre Wertheimer; 🇫🇷 Lyon, France

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