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

NCT ID: NCT04834830

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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

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Pleural Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

Examination of pleural effusion

Interventions

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

Examination of pleural effusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Daniela Gompelmann

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Daniela Gompelmann

Role: primary

0043 1 40400 47730

Other Identifiers

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Version 1.1 26.01.2021

Identifier Type: -

Identifier Source: org_study_id

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