NCT04974983

Brief Summary

This retrospective non - interventional patient chart review will be utilizing real world clinical data from patients treated for rGBM at the University Regensburg Medical center either with or without bevacizumab. Only patients will be analyzed who were potentially eligible for bevacizumab treatment. The study is designed to investigate the potential effects of bevacizumab treatment on the functional status, symptom burden, neurological deficits, time to tumor progression and overall survival between cohorts potentially eligible for bevacizumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

July 16, 2021

Last Update Submit

July 16, 2021

Conditions

GlioblastomaAngiogenesis

Keywords

GlioblastomaAngiogenesis

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Neurological deficits impacting functional independency

    15 months

Study Arms (2)

A

Treatment without bevacizumab

Other: Observation of neurological deficits

B

Treatment with bevacizumab

Other: Observation of neurological deficits

Interventions

Observation of neurological deficitsOTHER

Observation of neurological deficits

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recurrent glioblastoma either treated with or without bevacizumab

You may qualify if:

  • Diagnosis of recurrent glioblastoma

You may not qualify if:

  • Severe neurocognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Regensburg

Regensburg, 93042, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 23, 2021

Study Start

September 1, 2017

Primary Completion

June 30, 2020

Study Completion

August 30, 2020

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)