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Microparticles and Bronchiolitis Obliterans Syndrome (MIBO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02458274
First received: April 14, 2015
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

The main long-term complication of lung transplantation is chronic lung allograft dysfunction (CLAD). Bronchiolitis obliterans syndrome (BOS) is the most frequent presentation of CLAD. BOS leads to a progressive loss of lung allograft function, with recurrence of dyspnea and airflow limitation. In some advanced cases, patients need a lung re transplantation. The mechanisms of BOS are not completely elucidated, and there are no early markers or specific treatment available for this condition.

Microparticles (MPs) are submicron plasma membrane fragments released into the vascular compartment or the pericellular space in response to cell activation, injury or apoptosis. Broncho alveolar and circulating MPs may reflect cellular insults of the lung allografts. Therefore, MPs could be viewed either as biomarkers or as effectors of the chronic inflammatory or procoagulant processes leading to bronchiolitis obliterans syndrome.

The investigators plan to include 60 patients before lung transplantation at our centre in Strasbourg (France). Follow-up will be requested at the base of usual care (spirometry, blood sampling, bronchoscopy with broncho-alveolar lavage [BAL]). The investigators will measure at one month, one, two and three year post transplantation, the total concentration of MPs in plasma and BAL and characterize their phenotype.

The investigators objective is to demonstrate correlation between total MPs concentration in broncho-alveolar lavage fluid (BALF) and the occurrence of bronchiolitis obliterans syndrome at three years post lung transplantation.


Condition Intervention
Bronchiolitis Obliterans
Other: Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Circulating and Pulmonary Microparticles for Early Diagnosis of Bronchiolitis Obliterans Syndrome After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Correlation between total concentration of MPs in broncho-alveolar lavage fluid (BALF) and occurrence of bronchiolitis obliterans syndrome at three year post lung transplantation [ Time Frame: Lung transplanted patients will be followed up with usual care. Spirometry and bronchoscopy with BALF at three years after transplantation will be used in the present study. ]

    We will measure at three years post transplantation, the total concentration of MPs in plasma and BAL and characterize their phenotype Bronchiolitis Obliterans Syndrome (BOS) will be graded according to guidelines of the the International Society for Heart and Lung transplantation. Percentage of decrease of lung function based on actual FEV1 compared to the average of the two best FEV1, distant for three week, post lung transplantation.

    BOS 0 : FEV1 > 90% BOS 0-p : 90 >FEV1 > 81% BOS 1 : 80 >FEV1 > 66% BOS 0-p : 65 >FEV1 > 51% BOS 0-p : FEV1 < 50% If BOS is present, we usually do CT-scan and bronchoscopy with BALF to confirm BO and eliminate alternative diagnosis.



Secondary Outcome Measures:
  • Total concentration MPs and characterization of cellular origin of MPs in BALF and in plasma of patients at three year post lung transplantation. [ Time Frame: Lung transplanted patients will have spirometry and bronchoscopy with BALF at three years after transplantation as it's usually done for each lung transplanted. ]

    MPs expose to the surface phosphatidylserine (PhtdSer), tissue factor and membrane antigens from the parental cells.

    MPs collected from plasma and BALF will have differential centrifugation and concentrations of MPs will be measured using original functional multiwell assays.

    MPs will be captured onto annexin-5 (total MPs) or onto specific antibodies directed against membrane antigens borne by MPs and testifying their cell origin (CD104, CD66b, CD62E, CD62P, CD35, E105, CD14, CD3, CD20).



Biospecimen Retention:   Samples Without DNA
Plasma Broncho-alveolar lavage fluid

Estimated Enrollment: 60
Study Start Date: July 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient without bronchiolitis obliterans syndrome
Lung transplanted patient without bronchiolitis obliterans syndrome
Other: Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)
Patient with bronchiolitis obliterans syndrome
Patient with bronchiolitis obliterans syndrome three years after lung transplantation.
Other: Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

60 patients with a lung transplantation will be included in one center (Strasbourg) 30 -40 lung transplantations are performed each year in our centre, with a survival rate of 80% at three year post transplantation. Approx. 30% patients will develop BOS at three year post transplantation. So we expect at three year post transplantation 15 patients with BOS and 37 patients without BOS (52 patients alive at three years post transplantation).

Consequently, the total duration of the study will be five years (two years for inclusion and three years of follow-up)

Criteria

Inclusion criteria:

  • Every adult (>18 years) patient on lung transplant waiting list
  • Patients who give a written informed consent
  • Patients affiliated to a social security regimen

Exclusion criteria:

  • Patients on lung transplant waiting list for BOS
  • Patients who cannot sign an informed consent form (emergency situation, patient with understanding difficulties…)
  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: NCT02458274

Contacts
Contact: Leclercq Alexandre, MD 03 69 55 06 45 ext 33 alexandre.leclercq@chru-strasbourg.fr

Locations
France
CHU Strasbourg Recruiting
Strasbourg, France, +67000
Contact: LECLERCQ Alexandre, MD    03 69 55 06 45    alexandre.leclercq@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Leclercq Alexandre, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02458274     History of Changes
Other Study ID Numbers: 5254
Study First Received: April 14, 2015
Last Updated: May 27, 2015

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 25, 2017