Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

Completed

• Conditions: Glioblastoma

• Registration Number: NCT03770468
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:

* Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1)

* Identification of molecular tumor characteristics in long-term survivors (Focus 2)

* Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)

* Immunological studies (Focus 4)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-05
• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Status Verified: 2022-09
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

Inclusion Criteria

• Age > 18 years at diagnosis
• Histopathological diagnosis of glioblastoma (reference histology available) and
• Survival >5 years from diagnosis
• Availability of tumor tissue from initial glioblastoma diagnosis (FFPE or fresh-frozen) to validate the diagnosis centrally.
• Signed consent form (living patients) or ethics approval for anonymous data collection in case of retrospective analysis of deceased patients

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular profiling on frozen samples	1 year from last patient in	Samples will be subjected to microarray-based expression profiling
Molecular profiling on FFPE samples	1 year from last patient in	Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform
Overall Survival	1 year from last patient in
Proteome profiling	1 year from last patient in	Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry

Trial Locations

Locations (27)

CHRU de Lille; 🇫🇷 Lille, France

Hopitaux de Marseille - Hôpital de La Timone (APHM); 🇫🇷 Marseille, France

Technische Universitaet Muenchen - Klinikum Rechts Der Isar; 🇩🇪 Muenchen, Germany

Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern; 🇩🇪 Muenchen, Germany

Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS; 🇮🇹 Padova, Italy

Universitaetsklinikum - Essen; 🇩🇪 Essen, Germany

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

Ronellenfitsch Michael; 🇩🇪 Frankfurt, Germany

Universitaetsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Amsterdam UMC - locatie VUmc; 🇳🇱 Amsterdam, Netherlands

Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni; 🇮🇹 Torino, Italy

CHU d'Amiens - CHU Amiens - Hopital Sud; 🇫🇷 Salouël, France

UniversitaetsKlinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Dana-Farber Cancer Institute & Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

Institut du Cancer de Montpellier; 🇫🇷 Montpellier, France

Hopitaux de Paris - Hopital Saint-Louis; 🇫🇷 Paris, France

Universitaetsklinikum Bonn; 🇩🇪 Bonn, Germany

Hopitaux de Paris - La Pitie Salpetriere; 🇫🇷 Paris, France

Universitaetsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Univ. Spital Zurich; 🇨🇭 Zürich, Switzerland

Universitaetsklinikum Wien - AKH uniklinieken; 🇦🇹 Vienna, Austria

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Hopitaux Universitaires Bordet-Erasme; 🇧🇪 Brussel, Belgium

Hygeia Hospital; 🇬🇷 Athens, Greece

Centre Hospitalier Universitaire Vaudois - Lausanne; 🇨🇭 Lausanne, Switzerland

CHU de Nice - Hopital Pasteur; 🇫🇷 Nice, France

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Germany