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

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ClinicalTrials.gov Identifier: NCT03770468
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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

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Study Type : Observational
Estimated Enrollment : 640 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 : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: EORTC HQ +32 2 774 1611 1419@eortc.org

Locations
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France
CHRU de Lille Recruiting
Lille, France
Principal Investigator: Emilie Le Rhun, MD.         
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere Recruiting
Paris, France, 75651
Principal Investigator: Marc Sanson         
Greece
Hygeia Hospital Recruiting
Athens, Greece, 151 23
Principal Investigator: Evangelia Razis, MD         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03770468     History of Changes
Other Study ID Numbers: EORTC-1419-BTG
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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