Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNaestved Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Pleural effusion known or suspected of association with NSCLC (pleural fluid cytology positive for cells from NSCLC)
Patients must be able to give informed consent
Disqualifiers
Full oncodriver status measured in any pleural fluid in current work-up
Inability to understand written or spoken Danish.
Trial design
Design model
Single group
Treatments tested in this trial
meassurement of PD-L1, ALK, EGFR
Diagnostic testPD-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)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
Proportion of adequate and inadequate pleural fluid specimens
Time frame
assessed at 8-week follow-up2
Amounts of pleural fluid sent for analysis
Meassured in mL.
Time frame
assessed at 8-week follow-up3
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
Time frame
assessed at 8-week follow-up4
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
Time frame
assessed at 8-week follow-upSponsors and contacts
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Source ClinicalTrials.gov