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NCT Number: NCT05693727

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

pleural markers

Diagnostic Test

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

Primary outcomes

  1. Differentiate between malignant and non malignant pleural effusion by pleural markers

    Time frame: Baseline

    using pleural markers

Secondary outcomes

  1. Time saving

    Time frame: Baseline

    decrease the need for invasive maneuvers for diagnosis

    • decrease length of hospital stay
    • decrease the development of complications

Study contacts

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

Mona Adel Mostafa, Master

CONTACT

[email protected]

01124629683

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

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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