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Active, not recruiting Observational

PREdiction of Chronic LUng Allograft Dysfunction

NCT03967340 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2020-09-10
Last updated
2025-05-16

Condition(s) studied

Lung Transplant Rejection

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
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.

Primary outcome measure(s)

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

Trial sites (10)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France
CHU de Grenoble Grenoble France
Centre Chirurgical Marie Lannelongue Le Plessis-Robinson France
CHU de Lyon Lyon France
AP-HM Marseille France
CHU de Nantes Nantes France
Hôpital Bichat Paris France
CHRU de Strasbourg Strasbourg France
Hôpital Foch Suresnes France
CHU de Toulouse Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03967340 on ClinicalTrials.gov ↗ ← All trials in France