Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a prospective diagnostic pilot study to create hypotheses regarding immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.

Official Title
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Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer

Conditions
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Lung Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy Confirmed diagnosis of non-small cell lung cancer according to ERS guidelines Written informed consent Exclusion Criteria: Pregnancy and/or lactation Acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.) Any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure) Any medical, psychological or other condition impairing the patient's ability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC with pleural effusion<br>The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 Prevalence IHC | Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy. | At baseline | 
| PD-L1 Prevalence ICC | Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate | At baseline | 
| PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis | Based on all cases where PD-L1 analysis was indicated and sucessful (i.e. giving definite results), the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated: PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive. PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis | Based on all cases where PD-L1 analysis was indicated, the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated: PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive. PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive. In both instances, cases where PD-L1 analysis could not be performed were defined as negative. | At baseline | 
| Tumor Cell Detection in Pleural Effusion | Comparing the immunocytochemistry (ICC) analysis of pleural effusion concerning the detection of malignant tumor cells as compared to the immunohistochemistry analysis of pleural tissue. Seven cases of ICC analysis with inconclusive results were defined as negative. | At baseline |