Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion

Not yet recruiting

• Conditions: Pleural Effusion, Malignant

• Registration Number: NCT05693727
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion

Detailed Description

Pleural effusion is a common clinical entity affecting approximately 1.5 million patients per year in the United States. {3.1}A large number of diseases may be associated with pleural effusion.

This includes:

* Local conditions affecting the pleura (eg, tuberculous pleurisy, pleural mesothelioma),

* Extrapulmonary diseases with secondary pleural involvement (eg, chronic heart failure, liver cirrhosis).

To date, differentiation between both types of pleural effusion (exudate and transudate) is the most common initial diagnostic approach for patients with pleural effusion.

Exudative effusion is commonly seen in three conditions namely cancer (MPE), tuberculosis (TB) and para pneumonic Although MPE can be diagnosed by simple pleural fluid cytology, this method has significant limitations, including a highly variable sensitivity, ranging from as low as 11.6% to as high as 71%.

In contrast to other common causes of pleural effusion such as T.B, no accurate biomarkers of MPE have been established.

Several tumor markers were extensively evaluated, including carcinoembryonic antigen, cytokeratin-19 fragments, and cancer antigen 125, but none of them were found sensitive and specific enough to be implemented in routine clinical practice

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23
• Study Start: 2023-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Exclusion Criteria

• Age ˂ 18 years
• Refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentiate between malignant and non malignant pleural effusion by pleural markers	Baseline	using pleural markers

Secondary Outcome Measures

Name	Time	Method
Time saving	Baseline	decrease the need for invasive maneuvers for diagnosis; * decrease length of hospital stay; * decrease the development of complications