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PREdiction of Chronic LUng Allograft Dysfunction (PRELUD)

N

Nantes University Hospital (NUH)

Status

Active, not recruiting

Conditions

Lung Transplant Rejection

Study type

Observational

Funder types

Other

Identifiers

NCT03967340
RC18_0351

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

16+ years old

Volunteers

No 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.

Trial design

240 participants in 1 patient group

Lung transplant

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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