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Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer

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ClinicalTrials.gov Identifier: NCT01179685
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Unilatral Pleural Effusion Procedure: pleural fluid tapping Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: pleural fluid tapping
    Minimally invasive technique to detect malignant pleural effusion


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral pleural effusion on chest radiography

Exclusion Criteria:

  • body temperature > 38.3ºC and peripheral blood leukocytosis (>12,000/μl)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179685


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sang-Won Um, MD Samsung Medical Center

Responsible Party: Institutional Review Board, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179685     History of Changes
Other Study ID Numbers: 2008-08-043
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases