GlioblastomaNCT04974983
Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent Glioblastoma
An observational study of Glioblastoma and Angiogenesis, run by University Hospital Regensburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Angiogenesis
- What is being tested?
- Observation of neurological deficits
- How many people
- 203 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent glioblastoma either treated with or without bevacizumab
Who may be able to join
- Diagnosis of recurrent glioblastoma
Who cannot join
- Severe neurocognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent GBM: A Retrospective Patient Chart Review
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.
- Conditions
- Glioblastoma, Angiogenesis
- Being tested
- Observation of neurological deficits
- Keywords
- Glioblastoma, Angiogenesis
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of neurological deficitsOther
Observation of neurological deficits
| Study group | Role | What they receive |
|---|---|---|
| A | Treatment without bevacizumab Receives: Other: Observation of neurological deficits | |
| B | Treatment with bevacizumab Receives: Other: Observation of neurological deficits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Neurological deficits impacting functional independency
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Proescholdt, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974983
- Sponsor's protocol ID
- Z-2017-0901-5
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent GBM: A Retrospective Patient Chart Review
- ClinicalTrials.gov ID
- NCT04974983
- Acronym / sponsor ID
- Z-2017-0901-5
- Conditions
- Glioblastoma, Angiogenesis
- Keywords
- Glioblastoma, Angiogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Observation of neurological deficitsTreatment without bevacizumab |
| B | – | Other: Observation of neurological deficitsTreatment with bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent glioblastoma either treated with or without bevacizumab
Key inclusion criteria (1 listed)
- Diagnosis of recurrent glioblastoma
Key exclusion criteria (1 listed)
- Severe neurocognitive deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of neurological deficitsObservation of neurological deficits | Other | A, B |
Primary outcome
Functional outcome
Time frame: 15 months
Neurological deficits impacting functional independency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Angiogenesis, run by University Hospital Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.