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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05259605
Other study ID # EORTC-2013-BTG
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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