Back to resultsDiagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Primary Purpose
Unilatral Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pleural fluid tapping
Sponsored by
About this trial
This is an interventional diagnostic trial for Unilatral Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
- unilateral pleural effusion on chest radiography
Exclusion Criteria:
- body temperature > 38.3ºC and peripheral blood leukocytosis (>12,000/μl)
Sites / Locations
- Samsung Medical Center
Outcomes
Primary Outcome Measures
The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01179685
Brief Title
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Official Title
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta. The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilatral Pleural Effusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
pleural fluid tapping
Intervention Description
Minimally invasive technique to detect malignant pleural effusion
Primary Outcome Measure Information:
Title
The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.
Time Frame
12months interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral pleural effusion on chest radiography
Exclusion Criteria:
body temperature > 38.3ºC and peripheral blood leukocytosis (>12,000/μl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Won Um, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
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