Back to resultsFKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
Primary Purpose
Glioblastoma
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioblastoma
Eligibility Criteria
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
Sites / Locations
- Fondazione Policlinico Universitaro "A. Gemelli" IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Secondary Outcome Measures
Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival
Full Information
NCT ID
NCT05793021
First Posted
February 20, 2023
Last Updated
March 29, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05793021
Brief Title
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
Official Title
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood sample pre and post surgery to determine the level of FKBP51s protein
Primary Outcome Measure Information:
Title
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Time Frame
1 week
Title
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Gaudino, MD
Phone
0630155464
Ext
+39
Email
simona.gaudino@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Gaudino, MD
12. IPD Sharing Statement
Learn more about this trial
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
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