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

Lung Transplantation Clinical Trial

— COLT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00980967
• Other study ID #: BRD 09/1-F
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2009
• Last updated: May 11, 2015
• Start date: September 2009
• Est. completion date: September 2017

Study information

• Verified date: May 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Rejection
• Lung Transplantation

Intervention

Other:
• Study of predictive factors
Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No