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

NCT ID: NCT00980967

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2017-09-30

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.

Conditions

Chronic Rejection; Lung Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Study of predictive factors

Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHU de Nantes

Locations

CHU de Bordeaux

Bordeaux, , France

CHU de Grenoble

Grenoble, , France

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

CHU de Lyon

Lyon, , France

CHU de Marseille

Marseille, , France

CHU Nantes

Nantes, , France

HEGP

Paris, , France

Hôpital Bichat

Paris, , France

CHRU de Strasbourg

Strasbourg, , France

Hôpital Foch

Suresnes, , France

CHU de Toulouse

Toulouse, , France

Countries

France

References

Brugiere O, Dreyfuss D, Guilet R, Rong S, Hirschi S, Renaud-Picard B, Reynaud-Gaubert M, Coiffard B, Bunel V, Messika J, Demant X, Le Pavec J, Dauriat G, Saint Raymond C, Falque L, Mornex JF, Tissot A, Lair D, Le Borgne Krams A, Bousseau V, Magnan A, Picard C, Roux A, Glorion M, Carmagnat M, Gazeau F, Aubertin K, Carosella E, Vallee A, Landais C, Rouas-Freiss N, LeMaoult J; the COLT Consortium. Circulating Vesicular-bound HLA-G as Noninvasive Predictive Biomarker of CLAD After Lung Transplantation. Transplantation. 2025 Apr 1;109(4):736-745. doi: 10.1097/TP.0000000000005175. Epub 2024 Sep 19.

Reference Type: DERIVED

PMID: 39294868 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29571601 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28100545 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24585866 (View on PubMed)

Other Identifiers

BRD 09/1-F

Identifier Type: -

Identifier Source: org_study_id