N/A N=50

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

Lung Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02855281 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: PD-L1 Prevalence IHC — 21; 14; 8; 27 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wissenschaftliches Institut Bethanien e.V
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY PD-L1 Prevalence IHC	21; 14; 8; 27	—
PRIMARY PD-L1 Prevalence ICC	19; 6; 13; 12	—
PRIMARY PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis	100; 86; 63; 43; 45; 75	—
SECONDARY PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis	71; 71; 71; 64; 42; 71	—
SECONDARY Tumor Cell Detection in Pleural Effusion	83; 70; 92; 50	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02855281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.