Microparticles and Bronchiolitis Obliterans Syndrome

NCT02458274 | Completed

• 1 other identifier: 5254
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

• Correlation between total concentration of MPs in broncho-alveolar lavage fluid (BALF) and occurrence of bronchiolitis obliterans syndrome at three year post lung transplantation

  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.

  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 (1)

• Total concentration MPs and characterization of cellular origin of MPs in BALF and in plasma of patients at three year post lung transplantation.

  Lung transplanted patients will have spirometry and bronchoscopy with BALF at three years after transplantation as it's usually done for each lung transplanted.

Study Arms (2)

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)

Interventions

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

Patient with bronchiolitis obliterans syndrome; Patient without bronchiolitis obliterans syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

CHU Strasbourg

Strasbourg, +67000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Broncho-alveolar lavage fluid

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Leclercq Alexandre, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: June 1, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

FR (1)