Clinical trial · Observational
Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study
Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusions | — | UNRESOLVED | — |
| Pleural Effusion | — | UNRESOLVED | — |
| Tuberculous Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Tuberculous Pleural Effusion
- description
- Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy.
- interventionNames
- Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement
- label
- Malignant Pleural Effusion
- description
- Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings.
- interventionNames
- Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement
Primary outcomes (1)
- measure
- Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion
- timeFrame
- Within 1 year (from November 2022 to October 2023)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available