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OpenTrials
Completed

NCT Number: NCT03770468

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

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)

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Wien - AKH uniklinieken, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood drawl

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2018
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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