NCT03967340

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2020Mar 2027

First Submitted

Initial submission to the registry

May 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

6.5 years

First QC Date

May 22, 2019

Last Update Submit

May 13, 2025

Conditions

Lung Transplant Rejection

Keywords

chronic lung allograft dysfunctionlung transplantationbiomarkerspersonalized medecine

Outcome Measures

Primary Outcomes (1)

  • MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)

    3 years

Secondary Outcomes (4)

  • Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD

    3 years

  • MMP-9 levels over time associated with CLAD

    3 years

  • Transitional B lymphocytes rate over time associated with CLAD

    3 years

  • T lymphocytes levels over time associated with CLAD

    3 years

Study Arms (1)

Lung transplant

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU de Bordeaux

Bordeaux, 33604, France

Location

CHU de Grenoble

Grenoble, 38700, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHU de Lyon

Lyon, 69677, France

Location

AP-HM

Marseille, 13015, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and serum will be collected and retained in a biorepository

Study Officials

  • Adrien TISSOT, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 30, 2019

Study Start

September 10, 2020

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

FR(10)