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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05062772




Registration number
NCT05062772
Ethics application status
Date submitted
21/09/2021
Date registered
30/09/2021

Titles & IDs
Public title
Brain Tumor Intraoperative Ultrasound Database
Scientific title
Predicting Overall Survival in Glioblastomas Using Radiomic Features of Intraoperative Ultrasound. A Proposal for the Creation of an International Database of Brain Tumor Ultrasound Images
Secondary ID [1] 0 0
21-PI085
Universal Trial Number (UTN)
Trial acronym
BraTioUS-DB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Brain Neoplasms 0 0
Brain Cancer 0 0
Glioma 0 0
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Ultrasound

Glioblastoma -


Diagnosis / Prognosis: Ultrasound
Intraoperative ultrasound imaging
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Adult patients operated between January 2018 and January 2020 with a pathological diagnosis of WHO grade IV astrocytoma (Glioblastoma).
* Intraoperative ultrasound study that includes B-mode images
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other histopathological diagnoses. Even though the international database will be established in such a way that other tumor types can be included prospectively.
* Artifacts in ultrasound images that make their analysis impossible
* Stereotactic biopsies.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
India
State/province [1] 0 0
Parel
Country [2] 0 0
Italy
State/province [2] 0 0
Milan
Country [3] 0 0
Italy
State/province [3] 0 0
Palermo
Country [4] 0 0
Spain
State/province [4] 0 0
Valladolid

Funding & Sponsors
Primary sponsor type
Other
Name
Hospital del Rio Hortega
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Santiago Cepeda, MD, PhD
Address 0 0
Department of Neurosurgery University Hospital Río Hortega
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Santiago Cepeda, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+34651035158
Fax 0 0
Email 0 0
scepedac@saludcastillayleon.es
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05062772