Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.

NCT04806412 | Recruiting DMC

• 1 other identifier: SJ-889
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Pleural Effusion; Non-small Cell Lung Cancer

Outcome Measures

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

  assessed at 8 weeks follow-up

Secondary Outcomes (13)

• Proportion of adequate and inadequate pleural fluid specimens

  assessed at 8-week follow-up

• Amounts of pleural fluid sent for analysis

  assessed at 8-week follow-up

• Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status

  assessed at 8-week follow-up

• Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies

  assessed at 8-week follow-up

• Prevalence of oncodriver status in additional diagnostic interventions

  assessed at 8-week follow-up

Interventions

meassurement of PD-L1, ALK, EGFR DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Full oncodriver status measured in any pleural fluid in current work-up
• Inability to understand written or spoken Danish.

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (1)

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Genes, fms

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena

Central Study Contacts

Katrine Fjaellegaard, MD

CONTACT

31924375; kafj@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, non-randomized, cohort study

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: March 15, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2026

Record last verified: 2025-12

Locations

DK (1)