PREdiction of Chronic LUng Allograft Dysfunction

Lung Transplant Rejection Clinical Trial

— PRELUD  

Official title:

PREdiction of Chronic LUng Allograft Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03967340
• Other study ID #: RC18_0351
• Status: Active, not recruiting
• Start date: September 10, 2020
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplant Rejection

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)		3 years
Secondary	Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD		3 years
Secondary	MMP-9 levels over time associated with CLAD		3 years
Secondary	Transitional B lymphocytes rate over time associated with CLAD		3 years
Secondary	T lymphocytes levels over time associated with CLAD		3 years