The Prevalence of Oncodrivers in Malignant Pleural Effusions Associated With Non-small Cell Lung Cancer: A Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of oncodriver status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Full oncodriver status measured in any pleural fluid in current work-up
- •Inability to understand written or spoken Danish.
结局指标
主要结局
Prevalence of oncodriver status
时间窗: 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
次要结局
- 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)
- 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)
- 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)