Cancer Ratio and Cancer Ratio Plus in Malignant and Tuberculous Pleural Effusions

ConditionsMalignant Pleural Effusion Tuberculous Pleural Effusion

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSohag University

About this trial

This prospective observational analytical study aims to assess the diagnostic value of Cancer Ratio and Cancer Ratio Plus in differentiating malignant pleural effusion from tuberculous pleural effusion. Adult patients with confirmed malignant or tuberculous pleural effusion will be recruited from the Chest Diseases Department, Sohag University Hospitals. Clinical, laboratory, and radiological data will be collected, and the diagnostic performance of both markers will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

Patients with Malignant or tuberculous pleural effusion

Availability of complete pleural fluid analysis including lymphocyte percentage ,pleural fluid ADA, and Serum LDH level

Disqualifiers

Patients with mixed etiology effusions (e.g., malignancy with infection)

Prior pleural interventions affecting fluid analysis

Incomplete clinical or laboratory data

Trial population

The study will include patients presenting with malignant or tuberculous pleural effusions who are admitted to the Chest Diseases Department of Sohag University hospital

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Cancer Ratio and Cancer Ratio Plus
Diagnostic test
Cancer Ratio and Cancer Ratio Plus will be calculated using serum LDH, pleural fluid ADA, and pleural fluid lymphocyte percentage to assess their diagnostic value in differentiating malignant pleural effusion from tuberculous pleural effusion. 1. Cancer Ratio CR =Serum LDH /pleural fluid ADA . 2. Cancer Ratio Plus = Serum LDH/(pleural fluid ADA × pleural fluid Lymphocyte fraction )

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Malignant pleural effusion1 intervention

Group B: Tuberculous pleural effusion1 intervention

Trial outcomes

Primary outcomes

Diagnostic performance of Cancer Ratio and Cancer Ratio Plus in differentiating malignant from tuberculous pleural effusions

Diagnostic performance will be assessed by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cutoff values for differentiating malignant pleural effusion from tuberculous pleural effusion.

Time frame

through study completion, an average of 1 year.

Secondary outcomes

Correlation of Cancer Ratio and Cancer Ratio Plus with clinical and radiological characteristics

Assessment of the association between Cancer Ratio and Cancer Ratio Plus values and the clinical and radiological characteristics of patients with malignant and tuberculous pleural effusions.

Time frame

through study completion , an average of 1 year .

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

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