- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967340
PREdiction of Chronic LUng Allograft Dysfunction (PRELUD)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33604
- CHU de Bordeaux
-
Grenoble, France, 38700
- Chu de Grenoble
-
Le Plessis-Robinson, France, 92350
- Centre Chirurgical Marie Lannelongue
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Lyon, France, 69677
- CHU de Lyon
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Marseille, France, 13015
- AP-HM
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Nantes, France, 44093
- CHU de Nantes
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Paris, France, 75018
- Hôpital Bichat
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Strasbourg, France, 67091
- CHRU de Strasbourg
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Suresnes, France, 92151
- Hopital Foch
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Toulouse, France, 31059
- CHU de Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Lung transplant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD
Time Frame: 3 years
|
3 years
|
MMP-9 levels over time associated with CLAD
Time Frame: 3 years
|
3 years
|
Transitional B lymphocytes rate over time associated with CLAD
Time Frame: 3 years
|
3 years
|
T lymphocytes levels over time associated with CLAD
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrien TISSOT, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC18_0351
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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