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Active, Not Recruiting

NCT Number: NCT03967340

PREdiction of Chronic LUng Allograft Dysfunction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Transplant Rejection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. MMP-9 levels in plasma, gene expression and lymphocyte levels in blood associated with Chronic Lung Allograft Dysfunction (CLAD)

    Time frame: 3 years

Secondary outcomes

  1. Expression of the 3 genes BLK, POU2AF1 and TCL1A in whole blood associated with CLAD

    Time frame: 3 years

  2. MMP-9 levels over time associated with CLAD

    Time frame: 3 years

  3. Transitional B lymphocytes rate over time associated with CLAD

    Time frame: 3 years

  4. T lymphocytes levels over time associated with CLAD

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: PRELUD

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 30, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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