Official Title
The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Brief Title
Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Protocol ID
NCT04806412
Lead Sponsor
Naestved Hospital
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.
Detailed 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.
Study Period
-
Enrollment Count
100 participants
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Full oncodriver status measured in any pleural fluid in current work-up
- Inability to understand written or spoken Danish.
Filters
Malignant Pleural Effusion
Non-small Cell Lung Cancer
NA
UNKNOWN
ADULT
OLDER_ADULT