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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuberculous Pleural Effusion | Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy. |
| |
| Malignant Pleural Effusion | Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion | 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. | Within 1 year (from November 2022 to October 2023) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients aged 18 years and above who presented with lymphocytic exudative pleural effusion at the Thoracic Surgery Unit, Department of CTVS, MCVTC, and the Department of Pulmonology, TUTH, Kathmandu, Nepal. Participants were recruited based on specific inclusion and exclusion criteria. Diagnostic evaluations, including pleural fluid analysis and additional testing (e.g., ADA, AFB, GeneXpert, cytology, or biopsy), were conducted to classify cases as tuberculous or malignant pleural effusion. Only confirmed cases of these conditions were included in the final analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medicine, Maharajgunj | Kathmandu | 44600 | Nepal |
Data will be made available upon reasonable request for research purposes following publication of the study results
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|
|
| Within 1 year (from November 2022 to October 2023) |
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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