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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855281
• Other study ID #: WI_16-233
• Status: Completed
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2021
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Pleural Effusion

Locations

Country	Name	City	State
Germany	Wissenschaftliches Institut Bethanien e. V.	Solingen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	Institute of Pathology, University Clinic Düsseldorf, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD-L1 Prevalence IHC	Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.	At baseline
Primary	PD-L1 Prevalence ICC	Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate	At baseline
Primary	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	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
Secondary	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