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

NCT ID: NCT05693727

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2027-09-01

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

Conditions

Pleural Effusion, Malignant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

pleural markers

Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mona Adel

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mona Adel Mostafa, Master

Role: CONTACT

maiadel9995@gmail.co

01124629683

Related Links

https://pubmed.ncbi.nlm.nih.gov/25077579/

Saguil A, Wyrick K, Hallgren J. Diagnostic approach to pleural effusion. Am Fam Physician. 2014 Jul 15;90(2):99-104. PMID: 25077579.

https://pubmed.ncbi.nlm.nih.gov/30913213/

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

Other Identifiers

Malignant pleural effusion

Identifier Type: -

Identifier Source: org_study_id