Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion
研究概览
简要总结
The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion.
The main questions it aims to answer are:
Is pleural fluid Q-CRP significantly higher in tuberculous pleural effusion compared to malignant pleural effusion? What is the optimal cutoff value of pleural fluid Q-CRP to differentiate between these conditions?
Participants will:
Undergo diagnostic procedures such as pleural fluid analysis, including ADA and cytology.
Provide pleural fluid samples for Q-CRP measurement. Have additional diagnostic imaging or biopsies if clinically indicated.
Researchers will compare Q-CRP levels between the tuberculous pleural effusion group and the malignant pleural effusion group to determine its diagnostic accuracy, including sensitivity, specificity, and predictive value.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Adults aged 18 years and older.
- •Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
- •Lymphocyte predominance in pleural fluid (≥ 50% of differential count).
排除标准
- •Patients who refuse to provide consent for study participation.
- •Patients requiring biopsy under general anesthesia but found unfit for the procedure.
- •Non-tuberculous and non-malignant lymphocytic exudative pleural effusions identified during diagnostic evaluation.
结局指标
主要结局
Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion
时间窗: Within 1 year (from November 2022 to October 2023)
The primary outcome is the difference in pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels between patients diagnosed with tuberculous pleural effusion and those with malignant pleural effusion. The study evaluates the diagnostic utility of Q-CRP levels as a biomarker by comparing mean values, sensitivity, specificity, and Area Under the Receiver Operating Characteristic (ROC) curve for differentiation between the two conditions.
次要结局
- Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion(Within 1 year (from November 2022 to October 2023))
研究者
Asim Shrestha
Principal Investigator
Maharajgunj Medical Campus