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

Wissenschaftliches Institut Bethanien e.V50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wissenschaftliches Institut Bethanien e. V.

Solingen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

PD-L1 Prevalence IHC

Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.

Time frame: At baseline

PD-L1 Prevalence ICC

Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate

Time frame: 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.

Time frame: At baseline

Secondary Outcomes

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.

Time frame: 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.

Time frame: At baseline

Data from ClinicalTrials.gov

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