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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00980967
First received: September 11, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Chronic Rejection
Lung Transplantation
Other: Study of predictive factors

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: September 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Study of predictive factors
    Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980967

Locations
France
CHU Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHU de Nantes
ClinicalTrials.gov Identifier: NCT00980967     History of Changes
Other Study ID Numbers: BRD 09/1-F
Study First Received: September 11, 2009
Last Updated: September 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Lung transplantation
Chronic lung rejection
Obliterative bronchiolitis
Predictive factors

ClinicalTrials.gov processed this record on November 27, 2014