Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer
This study has been completed.
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179685
First received: August 10, 2010
Last updated: July 20, 2011
Last verified: July 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 10, 2010 | ||||
| Last Updated Date | July 20, 2011 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01179685 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer | ||||
| Official Title ICMJE | Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Unilatral Pleural Effusion | ||||
| Intervention ICMJE | Procedure: pleural fluid tapping
Minimally invasive technique to detect malignant pleural effusion |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01179685 | ||||
| Other Study ID Numbers ICMJE | 2008-08-043 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Institutional Review Board, Samsung Medical Center | ||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Samsung Medical Center | ||||
| Verification Date | July 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||