Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: meassurement of PD-L1, ALK, EGFR.
- Who it may be relevant to
- Registry conditions: Malignant Pleural Effusion, Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
Overview
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.
Interventions
- 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 subjecte
Primary outcome measures
- Prevalence of oncodriver status [Time frame: assessed at 8 weeks follow-up]
Secondary outcome measures (12)
- Proportion of adequate and inadequate pleural fluid specimens [Time frame: assessed at 8-week follow-up]
- Amounts of pleural fluid sent for analysis [Time frame: assessed at 8-week follow-up]
- Correlation between amounts of pleural fluid sent to the pathologist and the chance of obtaining oncodriver status [Time frame: assessed at 8-week follow-up]
- Number and type of additional diagnostic interventions including additional thoracentesis and cytological or histological biopsies [Time frame: assessed at 8-week follow-up]
- Prevalence of oncodriver status in additional diagnostic interventions [Time frame: assessed at 8-week follow-up]
- - Correlation between oncodriver status obtained in pleural fluid specimens and cytological or histological biopsies [Time frame: 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 [Time frame: assessed at 8-week follow-up]
- - Proportion of work-ups where full oncodriver-status was obtained at the second thoracentesis [Time frame: assessed at 8-week follow-up]
- - Proportion of patients with pleural fluid cytology negative of NSCLC, who is diagnosed with NSCLC. [Time frame: assessed at 8-week follow-up]
- Patient assessed pain during thoracentesis [Time frame: at day 1, 2 minutes after thoracentesis]
- Proportion of patients experiencing pneumothorax [Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up by evaluating the patient file]
- Proportion of patients experiencing bleeding [Time frame: assessed at day 1, 10 minutes after thoracentesis and 8-week follow-up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Næstved Sygehus, department of pulmonary medicine — Næstved
Identifiers
NCT: NCT04806412 · SJ-889