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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07766876
Acronym
CRPLUS-MPE-TPE
Enrollment
120
Registered
2026-08-17
Start date
2026-09-01
Completion date
2027-08-31
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Effusion, Tuberculous Pleural Effusion

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTCancer Ratio and Cancer Ratio Plus

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 )

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of Cancer Ratio and Cancer Ratio Plus in differentiating malignant from tuberculous pleural effusionsthrough 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

MeasureTime frameDescription
Correlation of Cancer Ratio and Cancer Ratio Plus with clinical and radiological characteristicsthrough 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.

Contacts

CONTACTDina MA Mohamed Ahmed, M.B.B.Ch.
Dina.Mohamed@med.sohag.edu.eg+201112561650
CONTACTEnas K Ahmed, Lecturer
+201022937527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026