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Pathogenesis of Primary Spontaneous Pneumothorax

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ClinicalTrials.gov Identifier: NCT01135004
Recruitment Status : Unknown
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 2, 2010
Last Update Posted : June 2, 2010
Sponsor:
Collaborators:
National Taiwan University Hospital, Yun-Lin Branch
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date May 30, 2010
First Posted Date June 2, 2010
Last Update Posted Date June 2, 2010
Study Start Date March 2010
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pathogenesis of Primary Spontaneous Pneumothorax
Official Title Molecular Pathogenesis of Primary Spontaneous Pneumothorax
Brief Summary Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.
Detailed Description Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients. The blebs resected from the pneumothorax patients will be used for RNA and protein levels analyses. The adjacent normal lung tissue will be used as a control for comparison.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Thoracoscopic bullectomy will be performed in spontaneous pneumothorax patients. Part of the surgcal specimen (lung tissue) will be obtained for RNA and protein analyses.
Sampling Method Non-Probability Sample
Study Population Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.
Condition Pneumothorax
Intervention Procedure: Thoracoscopic bullectomy
Thoracoscopic wedge resection of the diseased lung
Other Name: Video-assisted thoracic surgery (VATS)
Study Groups/Cohorts Pneumothorax patients
Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy
Intervention: Procedure: Thoracoscopic bullectomy
Publications * Ayed AK, Chandrasekaran C, Sukumar M. Video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: clinicopathological correlation. Eur J Cardiothorac Surg. 2006 Feb;29(2):221-5. Epub 2005 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†1,¬†2010)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2013
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age between 14 and 40 years
  • Spontaneous pneumothorax
  • Underwent bullectomy of the lung

Exclusion Criteria:

  • With underlying lung disease
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01135004
Other Study ID Numbers 200912060R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yung-Chie Lee, Professor, National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators
  • National Taiwan University Hospital, Yun-Lin Branch
  • National Science Council, Taiwan
Investigators
Study Chair: Yung-Chie Lee, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date March 2010