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Chronic RejectionCOLTNCT00980967

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

A study testing Study of predictive factors in people with Chronic Rejection and Lung Transplantation, run by Nantes University Hospital at 11 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rejection, Lung Transplantation
What is being tested?
Study of predictive factors
How many people
700 participants
Where
11 sitesFrance
Study dates
Sep 2009to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU de Bordeaux

    Bordeaux, 33604

  • CHU de Grenoble

    Grenoble, 38700

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson, 92350

  • CHU de Lyon

    Lyon, 69677

  • CHU de Marseille

    Marseille, 13015

  • CHU Nantes

    Nantes, 44093

  • HEGP

    Paris, 75015

  • Hôpital Bichat

    Paris, 75018

  • CHRU de Strasbourg

    Strasbourg, 67091

  • Hôpital Foch

    Suresnes, 92150

  • CHU de Toulouse

    Toulouse, 31059

Other trials in France

About this study

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.

Being tested
Study of predictive factors
Keywords
Lung transplantation, Chronic lung rejection, Obliterative bronchiolitis, Predictive factors
Medical subject headings
Bronchiolitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study of predictive factorsOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 years

Secondary outcomes (1)

  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.

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980967
Sponsor's protocol ID
BRD 09/1-F
Acronym
COLT
Status last verified
May 2015
First submitted
11 Sep 2009
Last updated
12 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41432731

  • 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.

    PubMed 39294868

  • 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.

    PubMed 29571601

  • 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.

    PubMed 28100545

  • 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.

    PubMed 24585866

Questions about this trial

What is this clinical trial studying?

A study testing Study of predictive factors in people with Chronic Rejection and Lung Transplantation, run by Nantes University Hospital at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980967, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.

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