NCT02152748

Brief Summary

Summary of scientific evidence and rationale of this project: Integrative molecular-genetic approaches have provided important insights in the biology of glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity but comprises different molecular subtypes, which are associated with a distinct genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio- and chemotherapy as well as the recent introduction of novel antiangiogenic agents have resulted in increasing survival times and improved quality-of-life of glioblastoma patients. Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma patients is limited, leading in virtually all cases to tumor recurrence and death of the patients. As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor recurrence (\< 10%), post-therapeutic samples are rare and no systematic, large-scale studies exist, which address post-therapeutic morphological and molecular alterations in glioblastoma tumor tissue. Yet, these data would help to improve the understanding of mechanisms involved in therapy-resistance and tumor progression, to develop new therapeutic approaches and could pave the way for personalized treatment strategies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

May 22, 2014

Last Update Submit

March 21, 2017

Conditions

Keywords

glioblastomamorphological and molecular changesprogressiontherapy-resistance

Outcome Measures

Primary Outcomes (2)

  • Morphology- based analysis

    Histopathological workup and evaluation

    24 months

  • Molecular analysis

    Assessment of genomic alterations at DNA-, RNA- and methylation level

    24 months

Study Arms (1)

Glioblastoma

The aim of this study is to analyze systematically morphological and molecular changes associated with glioblastoma progression and therapy-resistance in matched pre- and post-therapeutic glioblastoma samples.

Genetic: analyze systematically morphological and molecular changes associated with glioblastoma progression and therapy-resistance

Interventions

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Institute of Neurology

Vienna, Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Brain NeoplasmsGlioblastomaDisease Progression

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adelheid Wöhrer, MD PhD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.univ et scient.med.

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 2, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations