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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00980967
Acronym
COLT
Enrollment
700
Registered
2009-09-21
Start date
2009-09-30
Completion date
2017-09-30
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rejection, Lung Transplantation

Keywords

Lung transplantation, Chronic lung rejection, Obliterative bronchiolitis, Predictive factors

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.

Interventions

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026