Inflammatory Lung DiseasesNCT01171768
The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
An observational study of Inflammatory Lung Diseases and Hemoptysis, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Inflammatory Lung Diseases, Hemoptysis
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Dec 2010
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, peumonia and post-tuberculosis destroyed lung
Who may be able to join
- patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung
Who cannot join
- patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammatory Lung Diseases, Hemoptysis
- Keywords
- Vascular endothelial growth factor, angiopoietin-2
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemoptysis within 2 weeks | Not described | |
| patients without hemoptysis within 2 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis
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.
Measured: up to 7 days after enrollment
Secondary outcomes (1)
to investigate association between angiogenesis factors and other factors such as inflammatory biomarker and hypoxia.
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.
Measured: up to 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171768
- Sponsor's protocol ID
- 2008-05-043
- Status last verified
- Jul 2011
- First submitted
- 16 Jul 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis
- ClinicalTrials.gov ID
- NCT01171768
- Acronym / sponsor ID
- 2008-05-043
- Conditions
- Inflammatory Lung Diseases, Hemoptysis
- Keywords
- Vascular endothelial growth factor, angiopoietin-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jul 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hemoptysis within 2 weeks | – | – |
| patients without hemoptysis within 2 years | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, peumonia and post-tuberculosis destroyed lung
Key inclusion criteria (1 listed)
- patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung
Key exclusion criteria (1 listed)
- patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis
Time frame: up to 7 days after enrollment
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.
1 secondary outcome
to investigate association between angiogenesis factors and other factors such as inflammatory biomarker and hypoxia.
Time frame: up to 7 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Lung Diseases and Hemoptysis, run by Samsung Medical Center at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 21 Jul 2011. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum VEGF and Ang-2 level in lung inflammatory disease according to the presence of hemoptysis (time frame: up to 7 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2011.