Chronic Lung Allograft Dysfunction (CLAD)NCT02836938
Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction
An observational study of Chronic Lung Allograft Dysfunction (CLAD), run by Prof. Dr. Jens Hohlfeld at 1 site in Germany.
Trial summary
It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Lung Allograft Dysfunction (CLAD)
- What is being tested?
- Collection of exhaled breath volatile organic compounds
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to 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: Group of transplant patients with and without signs of BOS
Who may be able to join
- Outpatient bilateral lung transplant recipients including combined transplants
Who cannot join
- Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria
Trial locations and contacts
1 site in 1 country.
About this study
It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.
- Being tested
- Collection of exhaled breath volatile organic compounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of exhaled breath volatile organic compoundsOther
| Study group | Role | What they receive |
|---|---|---|
| Severe | Severe chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 3 Receives: Other: Collection of exhaled breath volatile organic compounds | |
| Mild | Mild chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 1-2 Receives: Other: Collection of exhaled breath volatile organic compounds | |
| Control | Bronchiolitis obliterans syndrome (BOS), stage 0 Receives: Other: Collection of exhaled breath volatile organic compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of exhaled breath volatile organic compounds
Measured: one sample will be collected between 6 month and 20 years after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung Allograft Dysfunction (CLAD)Studies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jens Hohlfeld
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor-investigator, Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836938
- Sponsor's protocol ID
- TXVOC
- Status last verified
- Feb 2017
- First submitted
- 5 Jul 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction
- ClinicalTrials.gov ID
- NCT02836938
- Acronym / sponsor ID
- TXVOC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prof. Dr. Jens HohlfeldUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jul 2016 (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.
It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe | – | Other: Collection of exhaled breath volatile organic compoundsSevere chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 3 |
| Mild | – | Other: Collection of exhaled breath volatile organic compoundsMild chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 1-2 |
| Control | – | Other: Collection of exhaled breath volatile organic compoundsBronchiolitis obliterans syndrome (BOS), stage 0 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group of transplant patients with and without signs of BOS
Key inclusion criteria (1 listed)
- Outpatient bilateral lung transplant recipients including combined transplants
Key exclusion criteria (1 listed)
- Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria
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 |
|---|---|---|
| Collection of exhaled breath volatile organic compounds | Other | Control, Mild, Severe |
Primary outcome
Concentration of exhaled breath volatile organic compounds
Time frame: one sample will be collected between 6 month and 20 years after lung transplantation
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 14 Feb 2017.
Related trials for Chronic Lung Allograft Dysfunction (CLAD)
RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingPhase 1/2
Chronic Lung Allograft Dysfunction MRI Study
Chronic Lung Allograft Dysfunction Lung MRI (CLAD)
RecruitingObservational study
Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
Lung Transplant Failure and Rejection, CLAD, Bronchiolitis Obliterans
RecruitingPhase 2
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
Bronchiolitis Obliterans Syndrome, Chronic Lung Allograft Dysfunction
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 Chronic Lung Allograft Dysfunction (CLAD), run by Prof. Dr. Jens Hohlfeld at 1 site in Germany.
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 14 Feb 2017. 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 Germany. 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?
Concentration of exhaled breath volatile organic compounds (time frame: one sample will be collected between 6 month and 20 years after lung transplantation). 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 14 Feb 2017.