This trial is active, not recruiting.

Conditions chronic rejection, lung transplantation
Treatment study of predictive factors
Sponsor Nantes University Hospital
Start date September 2009
End date September 2017
Trial size 700 participants
Trial identifier NCT00980967, BRD 09/1-F


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label

Primary Outcomes

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.
time frame: 8 years

Secondary Outcomes

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.
time frame: 8 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Nantes University Hospital.