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

NCT04834830 | Unknown

• 1 other identifier: Version 1.1 26.01.2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• To assess and compare the concentration of various cytokines and PD1-lymphoytes in malignant and benign pleural effusions

  12 months

Study Arms (1)

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.

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

Interventions

Pleural effusion will be examined for various cytokines and PD1-lymphocytes. DIAGNOSTIC_TEST

Examination of pleural effusion

Patients with pleural effusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Withdrawal or cessation of participation

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

AU (1)