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

Not Applicable

• Conditions: Chronic Rejection; Lung Transplantation

• Registration Number: NCT00980967
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (11)

CHU de Marseille; 🇫🇷 Marseille, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

CHU de Lyon; 🇫🇷 Lyon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU Nantes; 🇫🇷 Nantes, France

HEGP; 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Bichat; 🇫🇷 Paris, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Toulouse; 🇫🇷 Toulouse, France