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

Wissenschaftliches Institut Bethanien e.V

Status: Completed

Conditions: Lung Neoplasms

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02855281

WI_16-233

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

NSCLC with pleural effusion

Description:

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.