PREdiction of Chronic LUng Allograft Dysfunction

Active, not recruiting

• Conditions: Lung Transplant Rejection

• Registration Number: NCT03967340
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2020-09-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)	3 years

Secondary Outcome Measures

Name	Time	Method
T lymphocytes levels over time associated with CLAD	3 years
Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD	3 years
Transitional B lymphocytes rate over time associated with CLAD	3 years
MMP-9 levels over time associated with CLAD	3 years

Trial Locations

Locations (10)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Lyon; 🇫🇷 Lyon, France

Hôpital Bichat; 🇫🇷 Paris, France

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

AP-HM; 🇫🇷 Marseille, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Foch; 🇫🇷 Suresnes, France