The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis

This study has been completed.

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01171768

First received: July 16, 2010

Last updated: July 20, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 16, 2010
Last Updated Date	July 20, 2011
Start Date ^ICMJE	June 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 27, 2010)	serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis [ Time Frame: up to 7 days after enrollment ] [ Designated as safety issue: Yes ] We'll measure the serum VEFG and Ang-2 level of enrolled patients within a week from the moment that patients agree to enroll this study. Therefore, Comparison of the serum VEGF and Ang-2 level (measured within a week from enrollment) according to the presence of hemoptysis will be primary outcome.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01171768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 27, 2010)	to investigate association between angiogenesis factors and other factors such as inflammatory biomarker and hypoxia. [ Time Frame: up to 7 days after enrollment ] [ Designated as safety issue: Yes ] We'll measure the serum VEFG, Ang-2 level, and other factors such as inflammatory biomarkers and PaO2 of enrolled patients within a week from the moment that patients agree to enroll this study. Therefore, Investigating association between angiogensis factors and other factors such as inflammatory biomarker and hypoxia, which were measured within a week from enrollment, will be secondary outcome.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
Official Title ^ICMJE	The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
Brief Summary	Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF levels have been reported in inflammatory lung diseases, especially with hemoptysis, there was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the presence of hemoptysis, inflammatory biomarker and hypoxia.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, peumonia and post-tuberculosis destroyed lung
Condition ^ICMJE	Inflammatory Lung Diseases Hemoptysis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	patients with hemoptysis within 2 weeks patients without hemoptysis within 2 years
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	52
Completion Date	December 2010
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung Exclusion Criteria: patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment
Gender	Both
Ages	20 Years to 90 Years
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	NCT01171768
Other Study ID Numbers ^ICMJE	2008-05-043
Has Data Monitoring Committee	Not Provided
Responsible Party	Sang-Won Um, Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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