Clinical trial · Observational
Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
NCT02855281CI-TRIAL-00050481completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (3)
- measure
- PD-L1 Prevalence IHC
- timeFrame
- At baseline
- description
- Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
- measure
- PD-L1 Prevalence ICC
- timeFrame
- At baseline
- description
- Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHagmeyer 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. PMID 33778051