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NCT04834830 Clinical Trial

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

Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04834830
Other study ID # Version 1.1 26.01.2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2022

Study information
Verified date April 2021
Source University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Withdrawal or cessation of participation

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pleural effusion will be examined for various cytokines and PD1-lymphocytes.
Examination of pleural effusion

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions 12 months
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