Microparticles and Bronchiolitis Obliterans Syndrome

NCT ID: NCT02458274

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiolitis Obliterans

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient without bronchiolitis obliterans syndrome

Lung transplanted patient without bronchiolitis obliterans syndrome

Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)

Intervention Type OTHER

Patient with bronchiolitis obliterans syndrome

Patient with bronchiolitis obliterans syndrome three years after lung transplantation.

Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)

Intervention Type OTHER

Interventions

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Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)

Intervention Type OTHER

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leclercq Alexandre, MD

Role: PRINCIPAL_INVESTIGATOR

HĂ´pitaux Universitaires de Strasbourg

Locations

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CHU Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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5254

Identifier Type: -

Identifier Source: org_study_id

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