Impact of Bevacizumab on Symptom Burden and Neurological... | NCT04974983

Studies
Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent Glioblastoma

NCT04974983

Sponsor

University Hospital Regensburg

Status

Completed

Last Update Posted

Jul 23, 2021Actual

Enrollment

203Actual

Phase

Not provided

Conditions

Glioblastoma
Angiogenesis

Interventions

Observation of neurological deficits

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Aug 30, 2020Actual

First Submitted Date

Jul 16, 2021

First Submission Date that Met QC Criteria

Jul 16, 2021

First Posted Date

Jul 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2021

Last Update Posted Date

Jul 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Proescholdt, Professor of Neurosurgery, University Hospital RegensburgPrincipal Investigator

Lead Sponsor

University Hospital RegensburgOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Treatment without bevacizumab	Other: Observation of neurological deficits
B		Treatment with bevacizumab	Other: Observation of neurological deficits

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of neurological deficits	Other	Observation of neurological deficits	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome	Neurological deficits impacting functional independency	15 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of recurrent glioblastoma

Exclusion Criteria:

Severe neurocognitive deficits

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with recurrent glioblastoma either treated with or without bevacizumab

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Regensburg		Regensburg		93042	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided