Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770468
Recruitment Status : Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Glioblastoma Procedure: Blood drawl

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : July 5, 2015
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 year from last patient in ]
  2. 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

  3. Molecular profiling on frozen samples [ Time Frame: 1 year from last patient in ]
    Samples will be subjected to whole exome sequencing

  4. Molecular profiling on frozen samples [ Time Frame: 1 year from last patient in ]
    Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing

  5. Molecular profiling on frozen samples [ Time Frame: 1 year from last patient in ]
    Samples will be subjected to miRNA sequencing

  6. Molecular profiling on frozen samples [ Time Frame: 1 year from last patient in ]
    Samples will be subjected to microarray-based expression profiling

  7. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Glioblastoma patients with overall survival > 5 years
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770468


Locations
Show Show 27 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Layout table for investigator information
Principal Investigator: Michael Weller EORTC Study Coordinator
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03770468    
Other Study ID Numbers: EORTC-1419-BTG
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue