Clinical Identification of Malignant Pleural Effusions in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- Diagnosis of Malignancy
研究概览
简要总结
Pleural effusions (PE) are common conditions that signal either infection or cancer. The investigators aim to develop, validate, and prospectively assess the MAPED score, a clinical score that predicts malignancy at admission. This tool will assist clinicians all over the world to rapidly assess the probability of an effusion being malignant within 4 hours of admission.
详细描述
Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified.
Objective
To develop, validate, and prospectively assess markers of malignancy of PE at admission.
Methods: A prospective cohort of patients with PE from different etiologies will be recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed three times, at 40-month intervals since study initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pleural effusion
- •Hospital admission
- •No previous pleural procedure
- •Age > 18 years
- •No previous chemoradiotherapy
- •No antibiotic therapy during previous trimester
- •All history, chest X-ray, and pleural and blood cell counts and biochemistry entry data obtained within 4 hours after admission
排除标准
- •No diagnosis at one month post-admission
- •No informed consent provided
- •Age < 18 years
- •History, chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission
结局指标
主要结局
Diagnosis of Malignancy
时间窗: One month post-admission
Cytologic or histologic evidence of malignant cells or tissues in the pleural space.
次要结局
未报告次要终点
研究者
Georgios Stathopoulos
Associate Professor of Physiology
University of Patras