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

March 7, 2024 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

599

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Universitaetsklinikum Wien - AKH uniklinieken
  • Belgium
      • Brussel, Belgium, 1070
        • Hopitaux Universitaires Bordet-Erasme
  • France
      • Bron, France, 69677
        • CHU Lyon - Hopital neurologique Pierre Wertheimer
      • Lille, France
        • CHRU de Lille
      • Marseille, France, 13385
        • Hopitaux de Marseille - Hôpital de La Timone (APHM)
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier
      • Nice, France, 6000
        • CHU de Nice - Hopital Pasteur
      • Paris, France, 75475
        • Hopitaux de Paris - Hopital Saint-Louis
      • Paris, France, 75651
        • Hopitaux de Paris - La Pitie Salpetriere
      • Salouël, France, 80480
        • CHU d'Amiens - CHU Amiens - Hopital Sud
  • Germany
      • Bonn, Germany, 53105
        • Universitaetsklinikum Bonn
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Essen, Germany, 45147
        • Universitaetsklinikum - Essen
      • Frankfurt, Germany, 60528
        • Ronellenfitsch Michael
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Muenchen, Germany, 81675
        • Technische Universitaet Muenchen - Klinikum Rechts Der Isar
      • Muenchen, Germany, 81377
        • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
      • Regensburg, Germany, 93053
        • Universitaetsklinikum Regensburg
  • Greece
      • Athens, Greece, 151 23
        • Hygeia Hospital
  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni
  • Netherlands
      • Amsterdam, Netherlands, 1081HV
        • Amsterdam UMC - Locatie VUmc
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois - Lausanne
      • Zürich, Switzerland, 8091
        • Univ. Spital Zurich
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5450
        • Dana-Farber Cancer Institute & Harvard Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Glioblastoma patients with overall survival > 5 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Michael Weller, EORTC Study Coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2015

Primary Completion (Actual)

August 18, 2023

Study Completion (Actual)

August 18, 2023

Study Registration Dates

First Submitted

November 18, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1419-BTG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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