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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer; Malignant Pleural Effusion
• Intervention / Treatment: Diagnostic test: meassurement of PD-L1, ALK, EGFR

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrine Fjaellegaard, MD; Phone Number: 31924375; Email: kafj@regionsjaelland.dk

Study Locations

• Denmark
  • Region Sjælland
    • Næstved, Region Sjælland, Denmark, 4700
      • Recruiting
      • Næstved Sygehus, department of pulmonary medicine
      • Contact: katrine fjællegaard, MD; Phone Number: 20864959; Email: kafj@regionsjaelland.dk
      • Contact: Uffe Bødtger, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of adequate and inadequate pleural fluid specimens		assessed at 8-week follow-up
Amounts of pleural fluid sent for analysis	Meassured in mL.	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
- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies		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
- 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	assessed by a questionnaire containing a VAS (Visual Analogue Scale, scale 0-10, 0 being no pain, 10 being the worse pain)	at day 1, 2 minutes after thoracentesis
Proportion of patients experiencing pneumothorax		assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Proportion of patients experiencing bleeding		assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Proportion of complications leading to admission	assessed by evaluating the patient file	assessed at 8-week follow-up

Collaborators and Investigators

• Sponsor: Naestved Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): March 12, 2023
• Study Completion (Anticipated): May 12, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: SJ-889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No