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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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05693727
Collaborator
(none)
100
Enrollment
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: pleural markers

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2027

Outcome Measures

Primary Outcome Measures

  1. Differentiate between malignant and non malignant pleural effusion by pleural markers [Baseline]

    using pleural markers

Secondary Outcome Measures

  1. Time saving [Baseline]

    decrease the need for invasive maneuvers for diagnosis decrease length of hospital stay decrease the development of complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mona Adel, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05693727
Other Study ID Numbers:
  • Malignant pleural effusion
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pleural Effusion, Malignant
Pleural Effusion
Necrosis

Study Results

No Results Posted as of Jan 23, 2023