An interventional study of meassurement of PD-L1, ALK, EGFR in Malignant Pleural Effusion and Non-small Cell Lung Cancer, sponsored by Naestved Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Naestved Hospital · Not applicable, Interventional, and Diagnostic
Oncological treatment of patients with disseminated non-small cell lung cancer (NSCLC) is depending on the status of programmed death-ligand 1 (PD-L1), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR), so called oncodrivers. These can be measured in pleural fluid, but the prevalence is uncertain. In a prospective study, the research team aim to measure PD-L1, ALK and EGFR in patients with pleural fluid cytology positive for NSCLC to report the prevalence. Also, the study will investigate if the chance of obtaining oncodriver status is depending on the volume analysed and how the lack of oncodrivers influence the following work-up.
The study is a prospective, non-randomized, cohort study of patients with pleural effusion. Participants will be recruited from patients referred to the Pleura Clinic or admitted at the ward at the Department of Respiratory Medicine, Næstved Hospital, Næstved or at the Department of Respiratory Medicine, Zealand University Hospital, Roskilde, which is the two regional centres for workup of pleural effusions. Patients will be referred from either general practice or other hospital departments.
Pleural fluids with cytology positive for NSCLC will be tested for oncodrivers (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR).
Follow-up will be 8 weeks after inclusion.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →Naestved Hospital is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark). ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1. EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen)
Prevalence of oncodriver status
Prevalence of oncodriver status (for squamous cell carcinomas (SCC): PD-L1, for adenocarcinomas (AC): PD-L1, ALK and EGFR) in pleural fluid in patients with cytology positive for pulmonary NSCLC
Time frame: assessed at 8 weeks follow-up
Proportion of adequate and inadequate pleural fluid specimens
Time frame: assessed at 8-week follow-up
Amounts of pleural fluid sent for analysis
Meassured in mL.
Time frame: assessed at 8-week follow-up
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
Time frame: assessed at 8-week follow-up
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
Prevalence of oncodriver status in additional diagnostic interventions
Time frame: assessed at 8-week follow-up
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
- Proportion of work-ups where the lack of obtained oncodriver status in pleural fluid specimens leads to additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time frame: assessed at 8-week follow-up
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
Time frame: assessed at 8-week follow-up
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
Time frame: assessed at 8-week follow-up
Patient assessed pain during thoracentesis
assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)
Time frame: at day 1, 2 minutes after thoracentesis
Proportion of patients experiencing pneumothorax
Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Proportion of patients experiencing bleeding
Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Proportion of complications leading to admission
assessed by evaluating the patient file
Time frame: assessed at 8-week follow-up
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