Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

Study Overview
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Brief Summary
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Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins are implicated in this process, which have never been studied prospectively in a multicentric longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist in a large database, associated with a recipient bio-collection, and specific projects using these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation. Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum, bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be also taken. T cells, known to be involved in chronic rejection will be studied, and genomic, microarray and proteomic approaches will be used to detect further predictive factors. A study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also realised from blood samples. COLT will prove molecular markers to be predictive of early OB, before the development of severe airway obstruction and will allow the identification of patients at high risk of OB. COLT will identify potential targets for future treatments of OB. This collaborative project makes research and clinical teams working together, and creates the conditions of a long term network, extendable to other laboratories with new projects and additional European transplant centres.

Official Title
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Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

Conditions
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Chronic Rejection, Lung Transplantation

Intervention / Treatment
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* Other: Study of predictive factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults aged ≥ 18 years who have signed an Inform Consent Form double or heart-lung transplant recipients Exclusion Criteria: Pregnant or nursing women Patients with concomitant chronic inflammatory disease, independently of acute or chronic rejection or infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Study of predictive factors|Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients. This primary outcome will be evaluated at the end of the study. |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pertinence of a monitoring of lung chronic rejection based on the predictive factors identified in the study, in order to prevent this rejection. The secondary outcome measure will be evaluated at the end of the study. |  | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung transplantation, Chronic lung rejection, Obliterative bronchiolitis, Predictive factors