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

Completed

• Conditions: Pleural Effusion; Malignant Pleural Effusions; Tuberculous Pleural Effusion

• Registration Number: NCT06729931
• Lead Sponsor: Maharajgunj Medical Campus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion	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.

Secondary Outcome Measures

Name	Time	Method
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)	The secondary outcome evaluates the diagnostic performance of pleural fluid Q-CRP cut-off levels derived from the ROC curve analysis. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated to assess the utility of Q-CRP in accurately differentiating tuberculous pleural effusion from malignant pleural effusion.

Trial Locations

Locations (1)

Institute of Medicine, Maharajgunj; 🇳🇵 Kathmandu, Nepal