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

Pleural Effusion, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693727
• Other study ID #: Malignant pleural effusion
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Mona Adel Mostafa, Master
• Phone: 01124629683
• Email: maiadel9995[@]gmail.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Diagnostic Test:
• pleural markers
Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentiate between malignant and non malignant pleural effusion by pleural markers	using pleural markers	Baseline
Secondary	Time saving	decrease the need for invasive maneuvers for diagnosis; decrease length of hospital stay; decrease the development of complications	Baseline

External Links

•   Ashutosh Nath Aggarwal, Ritesh Agarwal, Inderpaul Singh Sehgal, Sahajal Dhooria. Adenosine deaminase for diagnosis of tuberculous pleural effusion: A systematic review and meta-analysis. PLoS ONE 14(3): e0213728
•   Saguil A, Wyrick K, Hallgren J. Diagnostic approach to pleural effusion. Am Fam Physician. 2014 Jul 15;90(2):99-104. PMID: 25077579.