- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mona Adel Mostafa, Master
- Phone Number: 01124629683
- Email: maiadel9995@gmail.co
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differentiate between malignant and non malignant pleural effusion by pleural markers
Time Frame: Baseline
|
using pleural markers
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time saving
Time Frame: Baseline
|
decrease the need for invasive maneuvers for diagnosis
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- Saguil A, Wyrick K, Hallgren J. Diagnostic approach to pleural effusion. Am Fam Physician. 2014 Jul 15;90(2):99-104. PMID: 25077579.
- 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
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Malignant pleural effusion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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