We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
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 : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date November 18, 2018
First Posted Date December 10, 2018
Last Update Posted Date September 15, 2022
Actual Study Start Date July 5, 2015
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2018)
  • 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
Original Primary Outcome Measures
 (submitted: December 6, 2018)
  • 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 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 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 (Orbitrap Elite)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Glioblastoma patients with overall survival > 5 years
Condition Glioblastoma
Intervention Procedure: Blood drawl
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 27, 2022)
599
Original Estimated Enrollment
 (submitted: December 6, 2018)
640
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   France,   Germany,   Greece,   Italy,   Netherlands,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03770468
Other Study ID Numbers EORTC-1419-BTG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Original Responsible Party Same as current
Current Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Michael Weller EORTC Study Coordinator
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2022