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

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.

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Key information

Conditions

Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tuberculous Pleural Effusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Cancer Ratio CR =Serum LDH /pleural fluid ADA .
Cancer Ratio Plus = Serum LDH/(pleural fluid ADA × pleural fluid Lymphocyte fraction )

Primary outcomes

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

Time frame: through study completion, an average of 1 year.

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.

Secondary outcomes

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

Time frame: through study completion , an average of 1 year .

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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+201112561650

Enas K Ahmed, Lecturer

CONTACT

+201022937527

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Role of Cancer Ratio and Cancer Ratio Plus in the Differentiation Between Malignant and Tuberculous Pleural Effusions .

Acronym: CRPLUS-MPE-TPE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 17, 2026
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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