Clinical trial NCT04806412: Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Official title: The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Pleural Effusion
Non-small Cell Lung Cancer
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, non-randomized, cohort study
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Prevalence of oncodriver status
timeFrame: assessed at 8 weeks follow-up
Secondary outcomes:
measure: Proportion of adequate and inadequate pleural fluid specimens
timeFrame: assessed at 8-week follow-up
measure: Amounts of pleural fluid sent for analysis
timeFrame: assessed at 8-week follow-up
measure: Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status
timeFrame: assessed at 8-week follow-up
measure: Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies
timeFrame: assessed at 8-week follow-up
measure: Prevalence of oncodriver status in additional diagnostic interventions
timeFrame: assessed at 8-week follow-up
measure: - Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies
timeFrame: assessed at 8-week follow-up
measure: - 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
timeFrame: assessed at 8-week follow-up
measure: - Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis
timeFrame: assessed at 8-week follow-up
measure: - Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.
timeFrame: assessed at 8-week follow-up
measure: Patient assessed pain during thoracentesis
timeFrame: at day 1, 2 minutes after thoracentesis
measure: Proportion of patients experiencing pneumothorax
timeFrame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
measure: Proportion of patients experiencing bleeding
timeFrame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
measure: Proportion of complications leading to admission
timeFrame: assessed at 8-week follow-up
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Sygehus, department of pulmonary medicine
state: Region Sjælland
Study officials:
References: