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

NCT07766876 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-7-19MS
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malignant Pleural Effusion; Tuberculous Pleural Effusion

Keywords

Cancer ratio; Cancer ratio plus; Serum LDH; Pleural fluid ADA; Pleural fluid analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year.

Secondary Outcomes (1)

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

  through study completion , an average of 1 year .

Study Arms (2)

Malignant pleural effusion

Diagnostic Test: Cancer Ratio and Cancer Ratio Plus

Tuberculous pleural effusion

Diagnostic Test: Cancer Ratio and Cancer Ratio Plus

Interventions

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 )

Malignant pleural effusion; Tuberculous pleural effusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• Patients with mixed etiology effusions (e.g., malignancy with infection)
• Prior pleural interventions affecting fluid analysis
• Incomplete clinical or laboratory data

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dina MA Mohamed Ahmed, M.B.B.Ch.

CONTACT

+201112561650; Dina.Mohamed@med.sohag.edu.eg

Enas K Ahmed, Lecturer

CONTACT

+201022937527

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at chest diseases department

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08