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

NCT06729931 | Completed DMC

• 1 other identifier: 225(6-11)E2079/080
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion; Malignant Pleural Effusions; Tuberculous Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Tuberculous Pleural Effusion

Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy.

Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement

Malignant Pleural Effusion

Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings.

Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement

Interventions

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.

Also known as: Pleural Fluid CRP, Quantitative CRP Analysis

Malignant Pleural Effusion; Tuberculous Pleural Effusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

Institute of Medicine, Maharajgunj

Kathmandu, 44600, Nepal

Location

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 12, 2024
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 15, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

NE (1)