NCT06729931

Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study

Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Maharajgunj Medical Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pleural Effusion
• Malignant Pleural Effusions
• Tuberculous Pleural Effusion

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement	The intervention involves the measurement of Quantitative C-Reactive Protein (Q-CRP) levels in pleural fluid obtained from patients presenting with lymphocytic exudative pleural effusion. The Q-CRP test is performed using standardized laboratory methods to quantitatively analyze CRP levels, which are then compared between patients with confirmed tuberculous pleural effusion and those with malignant pleural effusion. This diagnostic approach aims to evaluate the efficacy of pleural fluid Q-CRP as a biomarker to differentiate between these two conditions. No therapeutic or invasive interventions are introduced as part of this study beyond routine diagnostic procedures.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-11-01
• Completion: 2023-12-15
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: Nepal