Clincosm LogoSign in Get a demo

PRELUD: PREdiction of Chronic LUng Allograft Dysfunction

Sponsor
Nantes University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03967340
Collaborator
(none)
240
Enrollment
10
Locations
48.7
Anticipated Duration (Months)
24
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Sep 10, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Lung transplant

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD [3 years]

    2. MMP-9 levels over time associated with CLAD [3 years]

    3. Transitional B lymphocytes rate over time associated with CLAD [3 years]

    4. T lymphocytes levels over time associated with CLAD [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 CHU de Bordeaux Bordeaux France 33604
    2 CHU de Grenoble Grenoble France 38700
    3 Centre Chirurgical Marie Lannelongue Le Plessis-Robinson France 92350
    4 CHU de Lyon Lyon France 69677
    5 AP-HM Marseille France 13015
    6 CHU de Nantes Nantes France 44093
    7 Hôpital Bichat Paris France 75018
    8 CHRU de Strasbourg Strasbourg France 67091
    9 Hôpital Foch Suresnes France 92151
    10 CHU de Toulouse Toulouse France 31059

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Adrien TISSOT, Dr, CHU de Nantes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03967340
    Other Study ID Numbers:
    • RC18_0351
    First Posted:
    May 30, 2019
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Nov 1, 2021
    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

    Study Results

    No Results Posted as of Mar 17, 2022