NCT00980967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

8 years

First QC Date

September 11, 2009

Last Update Submit

May 11, 2015

Conditions

Chronic RejectionLung Transplantation

Keywords

Lung transplantationChronic lung rejectionObliterative bronchiolitisPredictive factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Study of predictive factorsOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults aged ≥ 18 years
  • who have signed an Inform Consent Form
  • double or heart-lung transplant recipients

You may not qualify if:

  • Pregnant or nursing women
  • Patients with concomitant chronic inflammatory disease, independently of acute or chronic rejection or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU de Bordeaux

Bordeaux, 33604, France

Location

CHU de Grenoble

Grenoble, 38700, France

Location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHU de Lyon

Lyon, 69677, France

Location

CHU de Marseille

Marseille, 13015, France

Location

CHU Nantes

Nantes, 44093, France

Location

HEGP

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Related Publications (5)

  • Reucherand B, Tissot A, Lacoste P, Roux A, Coiffard B, Demant X, Magnan A, Renaud-Picard B, Le Pavec J, Merveilleux C, Villeneuve T, Falque L, Salpin M, Carlier N, Knoop C, Reynaud-Gaubert M, Kessler R, Dauriat G, Lair D, Nieves A, Foucher Y, Roussel JC, Senage T; COLT Consortium. Effect of Donor Age on Survival in Lung Transplantation: A Multicentric Retrospective Study. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf420. doi: 10.1093/ejcts/ezaf420.

    PMID: 41432731DERIVED

  • 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.

    PMID: 39294868DERIVED

  • 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.

    PMID: 29571601DERIVED

  • 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.

    PMID: 28100545DERIVED

  • 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.

    PMID: 24585866DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 21, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

FR(11)