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

Phase

N/A

Condition

Lung Disease

Pleural Effusion

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT04806412

SJ-889

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18 years
Pleural effusion known or suspected of association with NSCLC (pleural fluid cytologypositive for cells from NSCLC)
Patients must be able to give informed consent

Exclusion

Exclusion Criteria:

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

Study Design

March 15, 2021

May 12, 2023

Study Description

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.

Connect with a study center

Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland 4700
Denmark
Active - Recruiting

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