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

Completed

• Conditions: Lung Neoplasms

• Registration Number: NCT02855281
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Study Start: 2016-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-02
• Results First Submitted: 2021-02-12
• Results First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Results First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis	At baseline	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.
PD-L1 Prevalence IHC	At baseline	Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
PD-L1 Prevalence ICC	At baseline	Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate

Secondary Outcome Measures

Name	Time	Method
Tumor Cell Detection in Pleural Effusion	At baseline	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.
PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis	At baseline	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.

Trial Locations

Locations (1)

Wissenschaftliches Institut Bethanien e. V.; 🇩🇪 Solingen, NRW, Germany