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Trial record 1 of 1 for:    prelud | France
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PREdiction of Chronic LUng Allograft Dysfunction (PRELUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967340
Recruitment Status : Active, not recruiting
First Posted : May 30, 2019
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief 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. 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.

Condition or disease
Lung Transplant Rejection

Study Design
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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PREdiction of Chronic LUng Allograft Dysfunction
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Lung transplant


Outcome Measures
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Primary Outcome Measures :
  1. MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD [ Time Frame: 3 years ]
  2. MMP-9 levels over time associated with CLAD [ Time Frame: 3 years ]
  3. Transitional B lymphocytes rate over time associated with CLAD [ Time Frame: 3 years ]
  4. T lymphocytes levels over time associated with CLAD [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
whole blood and serum will be collected and retained in a biorepository

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967340


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33604
CHU de Grenoble
Grenoble, France, 38700
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
CHU de Lyon
Lyon, France, 69677
AP-HM
Marseille, France, 13015
CHU de Nantes
Nantes, France, 44093
Hôpital Bichat
Paris, France, 75018
CHRU de Strasbourg
Strasbourg, France, 67091
Hôpital Foch
Suresnes, France, 92151
CHU de Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Adrien TISSOT, Dr CHU de Nantes
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03967340    
Other Study ID Numbers: RC18_0351
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
chronic lung allograft dysfunction
lung transplantation
biomarkers
personalized medecine