Lung Transplant RejectionPRELUDNCT03967340
PREdiction of Chronic LUng Allograft Dysfunction
An observational study of Lung Transplant Rejection, run by Nantes University Hospital at 10 sites in France.
Trial summary
Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Transplant Rejection
- How many people
- 240 participants
- Where
- 10 sitesFrance
- Study dates
- 10 Sep 2020to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly enrolled on the waiting list in transplant centres will be included in the PRELUD study. Based on the number of annual transplants in France (300/year), we plan to include 240 patients at the time of their registration on the transplant waiting list. Of these 240 patients, we estimate that 190 patients will be transplanted. It will be possible to include patients in emergencies. In this case, the consent of a trusted person or relative will be obtained and then the patient will give his or her consent as soon as his or her condition permits.
Who may be able to join
- Patients to receive lung transplants awaiting registration on the transplant waiting list
- Patients affiliated to a social security system
- Patients who have given their informed consent
- Patients weighing more than 26 kg
- Patients over 16 years of age
Who cannot join
- Pregnant or breastfeeding women
- Patients unable to follow the protocol
- Patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection.
- Patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Bordeaux
Bordeaux, 33604
CHU de Grenoble
Grenoble, 38700
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
CHU de Lyon
Lyon, 69677
AP-HM
Marseille, 13015
CHU de Nantes
Nantes, 44093
Hôpital Bichat
Paris, 75018
CHRU de Strasbourg
Strasbourg, 67091
Hôpital Foch
Suresnes, 92151
CHU de Toulouse
Toulouse, 31059
About this study
Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.
- Conditions
- Lung Transplant Rejection
- Keywords
- chronic lung allograft dysfunction, lung transplantation, biomarkers, personalized medecine
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 |
|---|---|---|
| Lung transplant | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)
Measured: 3 years
Secondary outcomes (4)
Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD
Measured: 3 years
MMP-9 levels over time associated with CLAD
Measured: 3 years
Transitional B lymphocytes rate over time associated with CLAD
Measured: 3 years
T lymphocytes levels over time associated with CLAD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Sep 2020
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien TISSOT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967340
- Sponsor's protocol ID
- RC18_0351
- Acronym
- PRELUD
- Status last verified
- May 2025
- First submitted
- 22 May 2019
- Last updated
- 16 May 2025
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREdiction of Chronic LUng Allograft Dysfunction
- ClinicalTrials.gov ID
- NCT03967340
- Acronym / sponsor ID
- PRELUD / RC18_0351
- Conditions
- Lung Transplant Rejection
- Keywords
- chronic lung allograft dysfunction, lung transplantation, biomarkers, personalized medecine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 May 2019 (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.
Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly enrolled on the waiting list in transplant centres will be included in the PRELUD study. Based on the number of annual transplants in France (300/year), we plan to include 240 patients at the time of their registration on the transplant waiting list. Of these 240 patients, we estimate that 190 patients will be transplanted. It will be possible to include patients in emergencies. In this case, the consent of a trusted person or relative will be obtained and then the patient will give his or her consent as soon as his or her condition permits.
Key inclusion criteria (5 listed)
- Patients to receive lung transplants awaiting registration on the transplant waiting list
- Patients affiliated to a social security system
- Patients who have given their informed consent
- Patients weighing more than 26 kg
- Patients over 16 years of age
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Patients unable to follow the protocol
- Patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection.
- Patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.
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
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)
Time frame: 3 years
4 secondary outcomes
Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD
Time frame: 3 years
MMP-9 levels over time associated with CLAD
Time frame: 3 years
Transitional B lymphocytes rate over time associated with CLAD
Time frame: 3 years
T lymphocytes levels over time associated with CLAD
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Related trials for Lung Transplant Rejection
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RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
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.
Adrien TISSOT, Dr principal investigator
Nantes University Hospital
10 sites 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 Rejection, run by Nantes University Hospital at 10 sites in France.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD) (time frame: 3 years). 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 16 May 2025.