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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03770468
Collaborator
(none)
599
Enrollment
27
Locations
93.8
Anticipated Duration (Months)
22.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood drawl

Study Design

Study Type:
Observational
Actual Enrollment :
599 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
Actual Study Start Date :
Jul 5, 2015
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [1 year from last patient in]

  2. 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

  3. Molecular profiling on frozen samples [1 year from last patient in]

    Samples will be subjected to whole exome sequencing

  4. Molecular profiling on frozen samples [1 year from last patient in]

    Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing

  5. Molecular profiling on frozen samples [1 year from last patient in]

    Samples will be subjected to miRNA sequencing

  6. Molecular profiling on frozen samples [1 year from last patient in]

    Samples will be subjected to microarray-based expression profiling

  7. Proteome profiling [1 year from last patient in]

    Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Michael Weller, EORTC Study Coordinator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT03770468
Other Study ID Numbers:
  • EORTC-1419-BTG
First Posted:
Dec 10, 2018
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glioblastoma

Study Results

No Results Posted as of May 31, 2022