- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01692444
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.
The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pessac, Francia, 33604
- University hospital of Bordeaux, Hôpital du Haut Lévêque
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male or female aged more than 40 yr
- Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.
- COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.
- Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
- with a written informed consent
Exclusion Criteria:
- Subject without any social security or health insurance
- Asthma, lung fibrosis or idiopathic pulmonary hypertension
- Chronic viral infections (hepatitis, HIV)
- Pregnant woman or breastfeeding
- Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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COPD
15 patients with COPD from 1 to 4 according to the GOLD 2011
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Non smoker Control
15 patients without COPD and no smoking history
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Smoker Control
15 patients without COPD but a smoking history
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
Periodo de tiempo: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
Periodo de tiempo: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Correlation between lung attenuation and the number of fibrocytes
Periodo de tiempo: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Correlation between plethysmography and the number of fibrocytes.
Periodo de tiempo: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Nicholas MOORE, MD-PhD, University Hospital, Bordeaux
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUBX 2011/34
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