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Not yet recruiting 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

Observational Pleural Effusion, Malignant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pleural markers.
Who it may be relevant to
Registry conditions: Pleural Effusion, Malignant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

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

Primary outcome measures

  • Differentiate between malignant and non malignant pleural effusion by pleural markers [Time frame: Baseline]
Secondary outcome measures (1)
  • Time saving [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05693727 · Malignant pleural effusion

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗