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NCT03770468 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03770468
Other study ID # EORTC-1419-BTG
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2015
Est. completion date August 18, 2023

Study information
Verified date September 2022
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 599
Est. completion date August 18, 2023
Est. primary completion date August 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood drawl

Locations
Country Name City State
Austria Universitaetsklinikum Wien - AKH uniklinieken Vienna
Belgium Hopitaux Universitaires Bordet-Erasme Brussel
France CHU Lyon - Hopital neurologique Pierre Wertheimer Bron
France CHRU de Lille Lille
France Hopitaux de Marseille - Hôpital de La Timone (APHM) Marseille
France Institut du Cancer de Montpellier Montpellier
France CHU de Nice - Hopital Pasteur Nice
France Hopitaux de Paris - Hopital Saint-Louis Paris
France Hopitaux de Paris - La Pitie Salpetriere Paris
France CHU d'Amiens - CHU Amiens - Hopital Sud Salouël
Germany Universitaetsklinikum Bonn Bonn
Germany Universitaetsklinikum Carl Gustav Carus Dresden
Germany Universitaetsklinikum - Essen Essen
Germany Ronellenfitsch Michael Frankfurt
Germany Universitaetsklinikum Freiburg Freiburg
Germany UniversitaetsKlinikum Heidelberg Heidelberg
Germany Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern Muenchen
Germany Technische Universitaet Muenchen - Klinikum Rechts Der Isar Muenchen
Germany Universitaetsklinikum Regensburg Regensburg
Greece Hygeia Hospital Athens
Italy Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS Padova
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni Torino
Netherlands Amsterdam UMC - locatie VUmc Amsterdam
Netherlands Erasmus MC Rotterdam
Switzerland Centre Hospitalier Universitaire Vaudois - Lausanne Lausanne
Switzerland Univ. Spital Zurich Zürich
United States Dana-Farber Cancer Institute & Harvard Medical School Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival 1 year from last patient in
Primary Molecular profiling on FFPE samples Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform 1 year from last patient in
Primary Molecular profiling on frozen samples Samples will be subjected to whole exome sequencing 1 year from last patient in
Primary Molecular profiling on frozen samples Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing 1 year from last patient in
Primary Molecular profiling on frozen samples Samples will be subjected to miRNA sequencing 1 year from last patient in
Primary Molecular profiling on frozen samples Samples will be subjected to microarray-based expression profiling 1 year from last patient in
Primary Proteome profiling Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry 1 year from last patient in
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