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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259605
• Other study ID #: EORTC-2013-BTG
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: December 15, 2026

Study information

• Verified date: March 2023
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: EORTC HQ
• Phone: +3227741611
• Email: eortc[@]eortc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: December 15, 2026
• Est. primary completion date: August 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Choroid Plexus Neoplasms
• Diffuse Midline Glioma, H3 K27M-Mutant
• Embryonal Tumor
• Ependymoma
• Germ Cell Tumor
• Glioma
• Hemangioblastoma
• Hemangiopericytoma
• Neoplasms
• Pineal Tumor
• Pineal Tumors
• Pinealoma
• Solitary Fibrous Tumors

Intervention

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.

Locations

Country	Name	City	State
Spain	Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals	Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.