Lung TransplantationNCT01204970
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
An observational study of Lung Transplantation and Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplantation, Chronic Obstructive Pulmonary Disease
- How many people
- 176 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Dec 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for a bronchoscopic procedure will be asked to undergo CLME. 3 pools will be made: COPD patients according to their pulmonary function test, lung transplant recipients and patients with normal spirometric results. In all groups the difference between active smokers and no-smokers will be made.
Who may be able to join
- referral for bronchoscopic investigation/sampling
- informed consent signed
- recent spirometric data
Who cannot join
- sedated and/or ventilated patients
- patients on ICU
- patients under oral anticoagulation
- co-existing lung disease
- acute infectious pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients
Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.
Read the detailed description
In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.
In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.
In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.
- Keywords
- Confocal Laser Scanning Microendoscopy, Small airways, COPD, Lung transplantation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| COPD | COPD Gold class 1-4 | |
| Transplant | Lung transplant recipients | |
| Control | Patients with normal spirometric data |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphometry
morpohometrical analysis at different time point after lung transplantation
Measured: 90 - 180 - 360 - 540 - 720 days
Secondary outcomes (1)
adverse events
bleeding, pneumothorax, pleuritic chest pain during procedure
Measured: 90 - 180 - 360- 540- 720 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2016
- Study completionDec 2016
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 Lung TransplantationStudies of the same condition, open and under way.
- 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
- Investigators
- Jonas Yserbyt, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenChistophe Dooms, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenMarc Decramer, MD, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenGeert Verleden, Md, PhD, Study chair, Universitaire Ziekenhuizen KU LeuvenWim Janssens, MD, PhD, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204970
- Sponsor's protocol ID
- B32220109292
- Status last verified
- Dec 2016
- First submitted
- 17 Sep 2010
- Last updated
- 30 Dec 2016
- Results posted
- No
Publications
Yserbyt J, Dooms C, Janssens W, Verleden GM. Endoscopic advanced imaging of the respiratory tract: exploring probe-based confocal laser endomicroscopy in emphysema. Thorax. 2018 Feb;73(2):188-190. doi: 10.1136/thoraxjnl-2016-209746. Epub 2017 Apr 14.
PubMed 28411249
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT01204970
- Acronym / sponsor ID
- B32220109292
- Keywords
- Confocal Laser Scanning Microendoscopy, Small airways, COPD, Lung transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Sep 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.
Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.
Detailed description
In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.
In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.
In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –COPD Gold class 1-4 |
| Transplant | – | –Lung transplant recipients |
| Control | – | –Patients with normal spirometric data |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for a bronchoscopic procedure will be asked to undergo CLME. 3 pools will be made: COPD patients according to their pulmonary function test, lung transplant recipients and patients with normal spirometric results. In all groups the difference between active smokers and no-smokers will be made.
Key inclusion criteria (3 listed)
- referral for bronchoscopic investigation/sampling
- informed consent signed
- recent spirometric data
Key exclusion criteria (5 listed)
- sedated and/or ventilated patients
- patients on ICU
- patients under oral anticoagulation
- co-existing lung disease
- acute infectious pulmonary disease
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
morphometry
Time frame: 90 - 180 - 360 - 540 - 720 days
morpohometrical analysis at different time point after lung transplantation
1 secondary outcome
adverse events
Time frame: 90 - 180 - 360- 540- 720 days
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 30 Dec 2016.
- Derived from this study: PubMed 28411249Yserbyt J, Dooms C, Janssens W, Verleden GM. Endoscopic advanced imaging of the respiratory tract: exploring probe-based confocal laser endomicroscopy in emphysema. Thorax. 2018 Feb;73(2):188-190. doi: 10.1136/thoraxjnl-2016-209746. Epub 2017 Apr 14.
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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.
Jonas Yserbyt, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Chistophe Dooms, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Marc Decramer, MD, PhD study chair
Universitaire Ziekenhuizen KU Leuven
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 Lung Transplantation and Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
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 5 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 30 Dec 2016. 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 Belgium. 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?
morphometry (time frame: 90 - 180 - 360 - 540 - 720 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01204970, 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 30 Dec 2016.