PREdiction of Chronic LUng Allograft Dysfunction

NCT ID: NCT03967340

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant Rejection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung transplant

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrien TISSOT, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Site Status

CHU de Lyon

Lyon, , France

Site Status

AP-HM

Marseille, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Hôpital Bichat

Paris, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC18_0351

Identifier Type: -

Identifier Source: org_study_id

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