FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05793021
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 53.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Diagnostic Test: Blood sample	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
• Actual Study Start Date: Jul 8, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm	Diagnostic Test: Blood sample; Blood sample pre and post surgery to determine the level of FKBP51s protein

Outcome Measures

Primary Outcome Measures

1. Correlation between FKBP51s protein concentration in Blood Cells and Disease flow [1 week]

2. Correlation between FKBP51s protein concentration in Blood Cells and Disease flow [3 months]

Secondary Outcome Measures

1. Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 18 years

• Diagnosis of Glioblastoma with surgery criteria

• Brain MRI with contrast both pre and post surgery

Exclusion Criteria:

• No availability of radiological documentation

• Glioblastoma diagnosis not confirmed by Histological examination

• Withdrawal of ICF

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitaro "A. Gemelli" IRCCS	Roma		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05793021
• Other Study ID Numbers: 3751
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioblastoma

Study Results

No Results Posted as of Mar 31, 2023