Clinical trial NCT03770468: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
Official title: Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2018-12-10
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Glioblastoma patients with overall survival \> 5 years

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)


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year from last patient in
measure: Molecular profiling on FFPE samples
timeFrame: 1 year from last patient in
measure: Molecular profiling on frozen samples
timeFrame: 1 year from last patient in
measure: Molecular profiling on frozen samples
timeFrame: 1 year from last patient in
measure: Molecular profiling on frozen samples
timeFrame: 1 year from last patient in
measure: Molecular profiling on frozen samples
timeFrame: 1 year from last patient in
measure: Proteome profiling
timeFrame: 1 year from last patient in
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute & Harvard Medical School
state: Massachusetts
city: Vienna
country: Austria
facility: Universitaetsklinikum Wien - AKH uniklinieken
city: Brussel
country: Belgium
facility: Hopitaux Universitaires Bordet-Erasme
city: Bron
country: France
facility: CHU Lyon - Hopital neurologique Pierre Wertheimer
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Hopitaux de Marseille - Hôpital de La Timone (APHM)
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Nice
country: France
facility: CHU de Nice - Hopital Pasteur
city: Paris
country: France
facility: Hopitaux de Paris - Hopital Saint-Louis
city: Paris
country: France
facility: Hopitaux de Paris - La Pitie Salpetriere
city: Salouël
country: France
facility: CHU d'Amiens - CHU Amiens - Hopital Sud
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Universitaetsklinikum - Essen
city: Frankfurt
country: Germany
facility: Ronellenfitsch Michael
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Heidelberg
country: Germany
facility: UniversitaetsKlinikum Heidelberg
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
city: Muenchen
country: Germany
facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Athens
country: Greece
facility: Hygeia Hospital
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - locatie VUmc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - Lausanne
city: Zürich
country: Switzerland
facility: Univ. Spital Zurich
Study officials:
affiliation: EORTC Study Coordinator
name: Michael Weller
role: PRINCIPAL_INVESTIGATOR
References: