GlioblastomaNCT03770468
Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
An observational study of Glioblastoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Blood drawl
- Type of treatment
- Surgery or procedure
- How many people
- 599 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 5 Jul 2015to 18 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glioblastoma patients with overall survival > 5 years
Who may be able to join
- 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
Who cannot join
- Not applicable
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
Germany9 sites
Universitaetsklinikum Bonn
Bonn, 53105
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Universitaetsklinikum - Essen
Essen, 45147
Ronellenfitsch Michael
Frankfurt, 60528
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
UniversitaetsKlinikum Heidelberg
Heidelberg, 69120
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
München, 81377
Technische Universitaet Muenchen - Klinikum Rechts Der Isar
München, 81675
Universitaetsklinikum Regensburg
Regensburg, 93053
France8 sites
CHU Lyon - Hopital neurologique Pierre Wertheimer
Bron, 69677
CHRU de Lille
Lille
Hopitaux de Marseille - Hôpital de La Timone (APHM)
Marseille, 13385
Institut du Cancer de Montpellier
Montpellier, 34298
CHU de Nice - Hopital Pasteur
Nice, 6000
Hopitaux de Paris - Hopital Saint-Louis
Paris, 75475
Hopitaux de Paris - La Pitie Salpetriere
Paris, 75651
CHU d'Amiens - CHU Amiens - Hopital Sud
Salouël, 80480
Italy2 sites
Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS
Padova, 35128
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni
Torino, 10126
Netherlands2 sites
Amsterdam UMC - locatie VUmc
Amsterdam, 1081HV
Erasmus MC
Rotterdam, 3015 GD
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne, 1011
Univ. Spital Zurich
Zurich, 8091
United States1 site
Dana-Farber Cancer Institute & Harvard Medical School
Boston, Massachusetts, 02115-5450
About this study
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)
- Conditions
- Glioblastoma
- Being tested
- Blood drawl
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 year from last patient in
Molecular profiling on FFPE samples
Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform
Measured: 1 year from last patient in
Molecular profiling on frozen samples
Samples will be subjected to whole exome sequencing
Measured: 1 year from last patient in
Molecular profiling on frozen samples
Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing
Measured: 1 year from last patient in
Molecular profiling on frozen samples
Samples will be subjected to miRNA sequencing
Measured: 1 year from last patient in
Molecular profiling on frozen samples
Samples will be subjected to microarray-based expression profiling
Measured: 1 year from last patient in
Proteome profiling
Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry
Measured: 1 year from last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start5 Jul 2015
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michael Weller, Principal investigator, EORTC Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770468
- Sponsor's protocol ID
- EORTC-1419-BTG
- Status last verified
- Sep 2022
- First submitted
- 18 Nov 2018
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
- ClinicalTrials.gov ID
- NCT03770468
- Acronym / sponsor ID
- EORTC-1419-BTG
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 5 Jul 2015 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glioblastoma patients with overall survival > 5 years
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawl | Procedure or surgery | – |
Primary outcome
Overall Survival
Time frame: 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
Molecular profiling on frozen samples
Time frame: 1 year from last patient in
Samples will be subjected to whole exome sequencing
Molecular profiling on frozen samples
Time frame: 1 year from last patient in
Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing
Molecular profiling on frozen samples
Time frame: 1 year from last patient in
Samples will be subjected to miRNA sequencing
Molecular profiling on frozen samples
Time frame: 1 year from last patient in
Samples will be subjected to microarray-based expression profiling
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Weller principal investigator
EORTC Study Coordinator
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, France, Italy, Netherlands, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year from last patient in). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.