Clinical trial NCT00980967: Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
Official title: Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Rejection
Lung Transplantation
Keywords: Lung transplantation
Chronic lung rejection
Obliterative bronchiolitis
Predictive factors
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 8 years
Secondary outcomes:
measure: 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.
timeFrame: 8 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: CHU de Marseille
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Bichat
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References:
citation: Durand M, Lacoste P, Danger R, Jacquemont L, Brosseau C, Durand E, Tilly G, Loy J, Foureau A, Royer PJ, Tissot A, Roux A, Reynaud-Gaubert M, Kessler R, Mussot S, Dromer C, Brugiere O, Mornex JF, Guillemain R, Claustre J, Degauque N, Magnan A, Brouard S; COLT and SysCLAD Consortia. High circulating CD4+CD25hiFOXP3+ T-cell sub-population early after lung transplantation is associated with development of bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2018 Jun;37(6):770-781. doi: 10.1016/j.healun.2018.01.1306. Epub 2018 Mar 20.
citation: Benmerad M, Slama R, Botturi K, Claustre J, Roux A, Sage E, Reynaud-Gaubert M, Gomez C, Kessler R, Brugiere O, Mornex JF, Mussot S, Dahan M, Boussaud V, Danner-Boucher I, Dromer C, Knoop C, Auffray A, Lepeule J, Malherbe L, Meleux F, Nicod L, Magnan A, Pison C, Siroux V; SysCLAD consortium. Chronic effects of air pollution on lung function after lung transplantation in the Systems prediction of Chronic Lung Allograft Dysfunction (SysCLAD) study. Eur Respir J. 2017 Jan 18;49(1):1600206. doi: 10.1183/13993003.00206-2016. Print 2017 Jan.
citation: Pison C, Magnan A, Botturi K, Seve M, Brouard S, Marsland BJ, Ernst F, Paprotka T, Deplanche K, Fritz A, Siroux V, Boissel JP, Corris PA, Auffray C, Nicod LP; SysCLAD consortium. Prediction of chronic lung allograft dysfunction: a systems medicine challenge. Eur Respir J. 2014 Mar;43(3):689-93. doi: 10.1183/09031936.00161313. No abstract available.