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

Not Applicable

• Conditions: Malignant Pleural Effusion; Non-small Cell Lung Cancer

• Registration Number: 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 Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17
• Primary Completion: 2023-03-12
• Study Completion: 2023-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prevalence of oncodriver status	assessed at 8 weeks follow-up	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

Secondary Outcome Measures

Name	Time	Method
Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status	assessed at 8-week follow-up
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies	assessed at 8-week follow-up
Proportion of complications leading to admission	assessed at 8-week follow-up	assessed by evaluating the patient file
Proportion of adequate and inadequate pleural fluid specimens	assessed at 8-week follow-up
- 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	assessed at 8-week follow-up
- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis	assessed at 8-week follow-up
Prevalence of oncodriver status in additional diagnostic interventions	assessed at 8-week follow-up
Proportion of patients experiencing pneumothorax	assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Amounts of pleural fluid sent for analysis	assessed at 8-week follow-up	Meassured in mL.
Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies	assessed at 8-week follow-up
Proportion of patients experiencing bleeding	assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.	assessed at 8-week follow-up
Patient assessed pain during thoracentesis	at day 1, 2 minutes after thoracentesis	assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)

Trial Locations

Locations (1)

Næstved Sygehus, department of pulmonary medicine; 🇩🇰 Næstved, Region Sjælland, Denmark