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

• Conditions: Pleural Effusion
• Interventions: Diagnostic Test: Pleural effusion will be examined for various cytokines and PD1-lymphocytes.

• Registration Number: NCT04834830
• Lead Sponsor: University of Vienna

Brief 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.

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 Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pleural effusion	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.

Primary Outcome Measures

Name	Time	Method
To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions	12 months

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria