NCT05793021

Brief Summary

The aim of this interventional study is to investigate the correlation between Magnetic Resonance Phenotype and levels of FKBP51s protein pre and post surgery in adult patients affected by Glioblastoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 8, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 31, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

February 20, 2023

Last Update Submit

March 29, 2023

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

  • Correlation between FKBP51s protein concentration in Blood Cells and Disease flow

    1 week

  • Correlation between FKBP51s protein concentration in Blood Cells and Disease flow

    3 months

Secondary Outcomes (1)

  • Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival

    1 year

Study Arms (1)

Single arm

OTHER
Diagnostic Test: Blood sample

Interventions

Blood sampleDIAGNOSTIC_TEST

Blood sample pre and post surgery to determine the level of FKBP51s protein

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years
  • Diagnosis of Glioblastoma with surgery criteria
  • Brain MRI with contrast both pre and post surgery

You may not qualify if:

  • No availability of radiological documentation
  • Glioblastoma diagnosis not confirmed by Histological examination
  • Withdrawal of ICF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Simona Gaudino, MD

CONTACT

0630155464simona.gaudino@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 31, 2023

Study Start

July 8, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

March 31, 2023

Record last verified: 2023-02

Locations

IT(1)