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

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 Overview

• Status: Completed
• Conditions: Lung Neoplasms

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Solingen, NRW, Germany, 42699
      • Wissenschaftliches Institut Bethanien e. V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

A patient in whom suspicion of pleural manifestation of lung cancer is not confirmed, will be considered a screening failure and thus excluded from the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

NSCLC with pleural effusion; 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?

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

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Collaborators: Merck Sharp & Dohme LLC; Institute of Pathology, University Clinic Düsseldorf

Publications and helpful links

General Publications

• Hagmeyer L, Schafer S, Engels M, Pietzke-Calcagnile A, Treml M, Herkenrath SD, Heldwein M, Hekmat K, Matthes S, Scheel A, Wolf J, Buttner R, Randerath W. High sensitivity of PD-L1 analysis from pleural effusion in nonsmall cell lung cancer. ERJ Open Res. 2021 Mar 22;7(1):00787-2020. doi: 10.1183/23120541.00787-2020. eCollection 2021 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Pleural Effusion
• Other Study ID Numbers: WI_16-233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No