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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806412
• Other study ID #: SJ-889
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2022
• Source: Naestved Hospital
• Contact: Katrine Fjaellegaard, MD
• Phone: 31924375
• Email: kafj[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 12, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignant Pleural Effusion
• Non-small Cell Lung Cancer
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Diagnostic Test:
• meassurement of PD-L1, ALK, EGFR
PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark). ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies "Origene" clone: OT1A4. Sample quality is assessed as for PD-L1. EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen)

Locations

Country	Name	City	State
Denmark	Næstved Sygehus, department of pulmonary medicine	Næstved	Region Sjælland

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of adequate and inadequate pleural fluid specimens		assessed at 8-week follow-up
Secondary	Amounts of pleural fluid sent for analysis	Meassured in mL.	assessed at 8-week follow-up
Secondary	Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status		assessed at 8-week follow-up
Secondary	Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies		assessed at 8-week follow-up
Secondary	Prevalence of oncodriver status in additional diagnostic interventions		assessed at 8-week follow-up
Secondary	- Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies		assessed at 8-week follow-up
Secondary	- 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
Secondary	- Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis		assessed at 8-week follow-up
Secondary	- Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC.		assessed at 8-week follow-up
Secondary	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
Secondary	Proportion of patients experiencing pneumothorax		assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file
Secondary	Proportion of patients experiencing bleeding		assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up
Secondary	Proportion of complications leading to admission	assessed by evaluating the patient file	assessed at 8-week follow-up