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

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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Key information

Conditions

Pleural Effusion Malignant Pleural Effusions Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tuberculous Pleural Effusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medicine, Maharajgunj

Kathmandu, 44600, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Pleural Fluid CRP, Quantitative CRP Analysis

Primary outcomes

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

Time frame: 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 outcomes

Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maharajgunj Medical Campus

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 12, 2024
Registry last updated: Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed