Clinical trial NCT02458274: Microparticles and Bronchiolitis Obliterans Syndrome
Official title: Circulating and Pulmonary Microparticles for Early Diagnosis of Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

Brief summary: 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.


Eligibility 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...)

Primary outcomes:
measure: Correlation between total concentration of MPs in broncho-alveolar lavage fluid (BALF) and occurrence of bronchiolitis obliterans syndrome at three year post lung transplantation
timeFrame: 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.
Secondary outcomes:
measure: Total concentration MPs and characterization of cellular origin of MPs in BALF and in plasma of patients at three year post lung transplantation.
timeFrame: Lung transplanted patients will have spirometry and bronchoscopy with BALF at three years after transplantation as it's usually done for each lung transplanted.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Leclercq Alexandre, MD
role: PRINCIPAL_INVESTIGATOR
References: