Clinical trial NCT06729931: Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study
Official title: Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Malignant Pleural Effusions
Tuberculous Pleural Effusion
Lead sponsor: Maharajgunj Medical Campus
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
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)
Secondary outcomes:
measure: Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion
timeFrame: Within 1 year (from November 2022 to October 2023)
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine, Maharajgunj
Study officials:
References: