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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Glioblastoma

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