Diagnostic Utility of Pleural Fluid MAGE Assay in Patient... | NCT01179685

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

NCT01179685

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jul 21, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Unilatral Pleural Effusion

Interventions

pleural fluid tapping

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 10, 2010

First Submission Date that Met QC Criteria

Aug 10, 2010

First Posted Date

Aug 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pleural fluid tapping	Procedure	Minimally invasive technique to detect malignant pleural effusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		12months interval

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral pleural effusion on chest radiography

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang-Won Um, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea