PREdiction of Chronic LUng Allograft Dysfunction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03967340

Acronym

PRELUD

Enrollment

240

Registered

2019-05-30

Start date

2020-09-10

Completion date

2027-03-31

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant Rejection

Keywords

chronic lung allograft dysfunction, lung transplantation, biomarkers, personalized medecine

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results