Clinical trial NCT02855281: Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
Official title: Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Heinrich-Heine University, Duesseldorf
First posted: 2016-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: PD-L1 Prevalence IHC
timeFrame: At baseline
measure: PD-L1 Prevalence ICC
timeFrame: At baseline
measure: PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis
timeFrame: At baseline
Secondary outcomes:
measure: PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis
timeFrame: At baseline
measure: Tumor Cell Detection in Pleural Effusion
timeFrame: At baseline
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien e. V.
state: NRW
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.