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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179685
First received: August 10, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention
Unilatral Pleural Effusion
Procedure: pleural fluid tapping

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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. [ Time Frame: 12months interval ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: pleural fluid tapping
    Minimally invasive technique to detect malignant pleural effusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Institutional Review Board, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179685     History of Changes
Other Study ID Numbers: 2008-08-043
Study First Received: August 10, 2010
Last Updated: July 20, 2011
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014