PneumothoraxNCT01135004
Pathogenesis of Primary Spontaneous Pneumothorax
An observational study of Pneumothorax, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Thoracoscopic bullectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.
Who may be able to join
- Age between 14 and 40 years
- Spontaneous pneumothorax
- Underwent bullectomy of the lung
Who cannot join
- With underlying lung disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Jin-Shing Chen, MD, PhD, 886-2-23123456 ext. 65178, chenjs@ntu.edu.tw
Yung-Chie Lee, MD, PhD
About this study
Official title: Molecular Pathogenesis of Primary Spontaneous Pneumothorax
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.
Read the 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.
- Conditions
- Pneumothorax
- Being tested
- Thoracoscopic bullectomy
- Keywords
- pneumothorax, thoracoscopy, pathogenesis, blebs, surgery
- Medical subject headings
- Pneumothorax, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic bullectomyProcedure or surgery
Also called Video-assisted thoracic surgery (VATS)
Thoracoscopic wedge resection of the diseased lung
| Study group | Role | What they receive |
|---|---|---|
| Pneumothorax patients | Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy Receives: Procedure: Thoracoscopic bullectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Science and Technology Council, Taiwan
- Investigators
- Yung-Chie Lee, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135004
- Sponsor's protocol ID
- 200912060R
- Status last verified
- Mar 2010
- First submitted
- 30 May 2010
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.ejcts.2005.11.005. Epub 2005 Dec 20.
PubMed 16376095
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Pathogenesis of Primary Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT01135004
- Acronym / sponsor ID
- 200912060R
- Conditions
- Pneumothorax
- Keywords
- pneumothorax, thoracoscopy, pathogenesis, blebs, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Science and Technology Council, Taiwan
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumothorax patients | – | Procedure: Thoracoscopic bullectomyPrimary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.
Key inclusion criteria (3 listed)
- Age between 14 and 40 years
- Spontaneous pneumothorax
- Underwent bullectomy of the lung
Key exclusion criteria (1 listed)
- With underlying lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracoscopic bullectomyAlso: Video-assisted thoracic surgery (VATS)Thoracoscopic wedge resection of the diseased lung | Procedure or surgery | Pneumothorax patients |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
- Background: PubMed 16376095Ayed 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. doi: 10.1016/j.ejcts.2005.11.005. Epub 2005 Dec 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yung-Chie Lee, MD, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Shing Chen, MD, PhD (886-2-23123456 ext. 65178, chenjs@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2010.