GlioblastomaNCT05793021
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
A study testing Blood sample in people with Glioblastoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Diagnosis of Glioblastoma with surgery criteria
- Brain MRI with contrast both pre and post surgery
Who cannot join
- No availability of radiological documentation
- Glioblastoma diagnosis not confirmed by Histological examination
- Withdrawal of ICF
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Roma, 00168
Simona Gaudino, MD
About this study
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
- Conditions
- Glioblastoma
- Being tested
- Blood sample
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sample pre and post surgery to determine the level of FKBP51s protein
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Not described Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Measured: 1 week
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Measured: 3 months
Secondary outcomes (1)
Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start8 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793021
- Sponsor's protocol ID
- 3751
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
- ClinicalTrials.gov ID
- NCT05793021
- Acronym / sponsor ID
- 3751
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Diagnosis of Glioblastoma with surgery criteria
- Brain MRI with contrast both pre and post surgery
Key exclusion criteria (3 listed)
- No availability of radiological documentation
- Glioblastoma diagnosis not confirmed by Histological examination
- Withdrawal of ICF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample pre and post surgery to determine the level of FKBP51s protein | Diagnostic test | Single arm |
Primary outcome
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Time frame: 1 week
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
Time frame: 3 months
1 secondary outcome
Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Glioblastoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Gaudino, MD (0630155464 ext. +39, simona.gaudino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between FKBP51s protein concentration in Blood Cells and Disease flow (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.