Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study
NCT ID: NCT06729931
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2022-11-01
2023-12-15
Brief Summary
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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
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tuberculous Pleural Effusion
Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy.
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.
Malignant Pleural Effusion
Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
* Lymphocyte predominance in pleural fluid (≥ 50% of differential count).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Maharajgunj Medical Campus
OTHER
Responsible Party
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Asim Shrestha
Principal Investigator
Locations
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Institute of Medicine, Maharajgunj
Kathmandu, , Nepal
Countries
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Other Identifiers
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225(6-11)E2079/080
Identifier Type: -
Identifier Source: org_study_id