Pleural EffusionNCT04834830
Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study
An observational study of Pleural Effusion, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Pleural effusion will be examined for various cytokines and PD1-lymphocytes.
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with malignant or benign pleural effusions requiring diagnostic and/or therapeutic procedures including thoracocentesis, drainage insertion, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery
Who may be able to join
- age >18 years
- radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons
- Signed declaration of consent
Who cannot join
- Withdrawal or cessation of participation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Daniela Gompelmann, 0043 1 40400 47730, daniela.gompelmann@meduniwien.ac.at
About this study
The aim of this study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions.
Read the detailed description
In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell.
- Conditions
- Pleural Effusion
- Being tested
- Pleural effusion will be examined for various cytokines and PD1-lymphocytes.
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural effusion will be examined for various cytokines and PD1-lymphocytes.Diagnostic test
Examination of pleural effusion
| Study group | Role | What they receive |
|---|---|---|
| Patients with pleural effusion | In patients with pleural effusion and indication for diagnostic and/or therapeutic procedures (thoracocentesis, drainage of fluid, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery), pleural fluid will be examined for various cytokines and PD1-lymphoctyes. Receives: Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Gompelmann, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834830
- Sponsor's protocol ID
- Version 1.1 26.01.2021
- Status last verified
- Apr 2021
- First submitted
- 4 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Importance of the PD-1/PD-L1 and the IL-10/IL-10R Axis in Malignant and Benign Pleural Effusions - a Pilot Study
- ClinicalTrials.gov ID
- NCT04834830
- Acronym / sponsor ID
- Version 1.1 26.01.2021
- Conditions
- Pleural Effusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 8 Apr 2021 (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 study is to evaluate the concentrations of interleukin-2, interleukin-10, interferon-gamma, PD1+ lymphocytes, and the interleukin-10 receptor expression in malignant and benign effusions.
Detailed description
In this prospective trial, 80 patients with pleural effusions and indication for thoracocentesis, drainage, indwelling pleural catheter (IPC) management and/or video-assisted thoracoscopic surgery are enrolled. The pleural effusion will be examined for different cytokines, cytokine-receptors, PD1-lymphocytes and CD4+/CD25+/Foxp3+ regulatory T cell.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pleural effusion | – | Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes.In patients with pleural effusion and indication for diagnostic and/or therapeutic procedures (thoracocentesis, drainage of fluid, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery), pleural fluid will be examined for various cytokines and PD1-lymphoctyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant or benign pleural effusions requiring diagnostic and/or therapeutic procedures including thoracocentesis, drainage insertion, indwelling pleural catheter (IPC) management, and/or video-assisted thoracoscopic surgery
Key inclusion criteria (3 listed)
- age >18 years
- radiologically confirmed pleural effusion with an indication for puncture, pleural drain insertion, or video-assisted thoracoscopy for diagnostic and/or therapeutic reasons
- Signed declaration of consent
Key exclusion criteria (1 listed)
- Withdrawal or cessation of participation
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 |
|---|---|---|
| Pleural effusion will be examined for various cytokines and PD1-lymphocytes.Examination of pleural effusion | Diagnostic test | Patients with pleural effusion |
Primary outcome
To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Pleural Effusion, run by University of Vienna at 1 site in Austria.
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 1 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 8 Apr 2021. 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 Austria. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions (time frame: 12 months). 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 8 Apr 2021.