Lung Transplant Failure and RejectionNCT04558333
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
An observational study of Lung Transplant Failure and Rejection and Primary Graft Dysfunction, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure and Rejection, Primary Graft Dysfunction
- What is being tested?
- blood and exhaled breath specimens
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Oct 2019to 28 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all lung transplant recipients
Who may be able to join
- all lung transplant recipients > 18 years signed ICF (informed consent form)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.
Read the detailed description
At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.
- Being tested
- blood and exhaled breath specimens
- Medical subject headings
- Rejection, Psychology, Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and exhaled breath specimensOther
identification of possible biomarkers
| Study group | Role | What they receive |
|---|---|---|
| LTx (lung transplant) patients | identification of possible biomarkers Receives: Other: blood and exhaled breath specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
death
Measured: up to 520 weeks
Secondary outcomes (1)
Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.
PGD
Measured: from transplantation till 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start28 Oct 2019
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: lack of resources (personnel and budget)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Therese Lapperre, University Hospital, Antwerp
- Investigators
- Thérèse Lapperre, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558333
- Sponsor's protocol ID
- CLAD
- Status last verified
- May 2024
- First submitted
- 9 Sep 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
- ClinicalTrials.gov ID
- NCT04558333
- Acronym / sponsor ID
- CLAD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of resources (personnel and budget)
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 22 Sep 2020 (actual)
- 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.
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.
Detailed description
At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTx (lung transplant) patients | – | Other: blood and exhaled breath specimensidentification of possible biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all lung transplant recipients
Key inclusion criteria (1 listed)
- all lung transplant recipients > 18 years signed ICF (informed consent form)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| blood and exhaled breath specimensidentification of possible biomarkers | Other | LTx (lung transplant) patients |
Primary outcome
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
Time frame: up to 520 weeks
death
1 secondary outcome
Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.
Time frame: from transplantation till 72 hours after surgery
Results and safety
The study was stopped early (reason given: lack of resources (personnel and budget)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Related trials for Lung Transplant Failure and Rejection
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
RecruitingObservational study
Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
Lung Transplant Failure and Rejection, CLAD, Bronchiolitis Obliterans
Active, not recruitingObservational study
AlloSure Lung Assessment and Metagenomics Outcomes Study
Lung Transplant Infection, Lung Transplant; Complications
Enrolling by invitationObservational study
Long Term Follow up of the LTOG Cohort
Lung Transplant Failure and Rejection
RecruitingObservational study
Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
Lung Transplant Failure and Rejection, Lung Transplant Infection
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.
Thérèse Lapperre, MD principal investigator
University Hospital, Antwerp
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 Transplant Failure and Rejection and Primary Graft Dysfunction, run by University Hospital, Antwerp 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 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: stopped early, as of the sponsor's last update on 3 May 2024. 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 was stopped early (reason given: lack of resources (personnel and budget)). Results are not available in the source record.
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?
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation. (time frame: up to 520 weeks). 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 3 May 2024.