NCT05229198

Brief Summary

This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma. The prospective multicenter international dataset compiled during the ALBATROSS project will include a cohort up to 300 new patients diagnosed with GB after June 1, 2020. Longitudinal images (T1, T2, T1c, FLAIR, PWI-DSC and DWI at least), complete molecular profiling, primary and secondary lines of treatment and clinical conditions will be included for each patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 8, 2025

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 27, 2022

Last Update Submit

July 2, 2025

Conditions

Astrocytoma, Grade IV

Keywords

Astrocytoma, Grade IVGlioblastomaGlioblastoma IDH wildtypeAstrocytoma IDH mutantGlioblastoma IDH mutantHigh-grade glioma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Overall Survival is defined as the time from the first presurgical MRI is taken to the patient (MR0) to death

    From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months

Secondary Outcomes (1)

  • Progression Free Survival (PFS)

    From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 months

Eligibility Criteria

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

Adults patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment

You may qualify if:

  • Patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment
  • Age \> 18 years at diagnosis
  • Patients with access to complete preoperative, postoperative and follow up MRI studies, including:
  • Pre gadolinium T1-weighted MRI
  • Post gadolinium T1-wighted MRI
  • T2-weighted MRI
  • Fluid-Attenuated Inversion Recovery (FLAIR)
  • Dynamic Susceptibility Contrast (DSC) T2\*-weighted perfusion sequences
  • Diffusion Weighted Imaging (DWI)
  • Patients who undergo surgery with the possibility to collect samples from different regions of the tumor

You may not qualify if:

  • Patient with congestive heart failure within 6 months prior to study entry (New York Heart Association \>= Grade 3)
  • Uncontrolled or significant cardiovascular disease, including:
  • Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
  • Uncontrolled angina within 6 months
  • Diagnosed or suspected congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Clinically significant abnormality on electrocardiogram (ECG)
  • Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Politècnica de València

Valencia, Valencia, 46021, Spain

Location

MeSH Terms

Conditions

GlioblastomaGlioma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Main Researcher. Head of Biomedical Data Science Lab at UPV

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

June 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2023

Last Updated

July 8, 2025

Record last verified: 2022-02

Locations

ES(1)