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Creation of a Biological Collection of BRonchiaI and Pulmonary Tissues From Surgical wastE (BRISE)

19 de agosto de 2026 actualizado por: University Hospital, Bordeaux
The biological samples and associated data will facilitate the successful implementation of the research collaboration between Bordeaux University Hospital and the University of Bordeaux on the pathophysiology of bronchopulmonary diseases. In the longer term, this research could lead to the discovery of new therapeutic targets for asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, and acute respiratory distress syndrome.

Descripción general del estudio

Descripción detallada

Bronchial obstructive diseases, such as asthma and chronic obstructive pulmonary disease (COPD), are very common and pose a major public health problem. Asthma affects about 7% and COPD affects 3% of the population in France. In children, the prevalence of asthma is even higher and can reach 15 to 20%. These two diseases are responsible for many hospitalizations and emergency room stays. While asthma mortality has been considerably reduced over the last 30 years, COPD mortality continues to increase to reach the 3rd leading cause of mortality. In COPD, pulmonary hypertension (PH) is a common comorbidity that increases mortality.

In each of these diseases, bronchial remodeling occurs from the beginning of the disease, including in children. Long considered an abnormal process of tissue repair after inflammation, it is now considered to be concomitant with bronchial inflammation. It conditions the prognosis of the disease but its pathophysiological processes remain largely unknown.

In asthma, bronchial remodeling is characterized by epithelial abrasion, pseudo-thickening of the basement membrane, bronchial fibrosis, hypertrophy of the submucosal glands, neoangiogenesis and increased bronchial smooth muscle mass. In the laboratory, the investigators have shown that the mechanisms responsible for this increase in bronchial smooth muscle mass are complex and involve in particular the mitochondria of bronchial smooth muscle in both adults and children.

In COPD, bronchial remodeling is characterized by epithelial metaplasia, hypertrophy of the submucosal glands, peribronchial fibrosis, and increased bronchial smooth muscle mass.

In the laboratory, it has been shown that fibrocytes are involved in peribronchial fibrosis. In addition, at the level of the lung parenchyma, there is a destruction of the distal airway spaces responsible for pulmonary emphysema. In some COPD patients, pulmonary hypertension occurs and is accompanied by remodeling of the pulmonary arteries with thickening of the media, and pulmonary arterial fibrosis.

Apart from adult acute respiratory distress syndrome (ARDS), it is an acute disease with a high risk of secondary pulmonary fibrosis. This is characterized by alveolar fibrosis with a proliferation of fibroblasts.

The COBRA cohort (Bronchial Obstruction and Asthma Cohort), sponsored by INSERM, makes it possible to obtain, with the consent of patients, bronchial tissues, blood, sputum of adult asthma or COPD patients from bronchial biopsies and brushing, Boncho-Alveolar lavage (BAL) obtained during bronchial fiberscopies, blood, sputum.

The results of experiments on asthmatic tissues should be compared with those from non-asthmatic subjects. In adults, these tissues come from surgical waste during lobectomy/pneumonectomy or lung transplantation. In children, these tissues are collected as part of the ARISE, BIRDIES, VIRCHILLD and more recently ICEBERG protocols (all promoted by the Bordeaux University Hospital) which make it possible to perform bronchial brushing and/or bronchial biopsies during bronchial fiberscopy, nasal brushing, surgical waste during a lobectomy and blood. These tissues thus make it possible to cultivate these same smooth muscle cells and bronchial epithelial cells. Adult surgical waste also makes it possible to grow cells from COPD patients at different stages of severity. They also make it possible to extract and culture other cell types involved in the pathophysiology of COPD such as fibrocytes, pneumocytes, endothelial and pulmonary vascular smooth muscle cells and other inflammatory cells such as lymphocytes, neutrophils, macrophages, mast cells, etc. This is because the immune cells in lung tissue are different from those in circulating blood. All of these cell types can be cultured in organoid models of bronchi, alveoli, submucosal glands, or even pulmonary vessels.

Depending on the respiratory function of the operated patients, measured pre-operatively, the bronchial/parenchymal and arterial pulmonary tissues may reflect a "healthy" tissue (non-asthmatic, non-COPD) or mild to severe COPD with or without pulmonary hypertension.

Tipo de estudio

De observación

Inscripción (Estimado)

650

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Pessac, Francia, 33604
        • CHU de Bordeaux
        • Investigador principal:
          • Patrick BERGER, MD, PhD
        • Contacto:
          • Patrick BERGER, PUPH
          • Número de teléfono: (+33)05 57 65 65 13

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

The population includes male and female participants of all ages (adults and children) who are undergoing or require specific thoracic or bronchial procedures, sputum, nasal brushing, blood as part of clinical care or research. These procedures are conducted under the auspices of Bordeaux University Hospital (e.g., ARISE, BIRDIES, ICEBERG, VIRCHILLD) or Inserm (e.g., COBRA).

Descripción

Inclusion Criteria:

  • Male or female
  • Adult or children
  • Having required or necessitating, in the context of care or research involving the human person promoted by the Bordeaux University Hospital (ARISE, BIRDIES, ICEBERG, VIRCHILLD) or by Inserm (COBRA), either thoracic surgery such as lobectomy, pneumonectomy or lung transplantation in the Thoracic Surgery Department of the Haut Lévêque Hospital, or bronchial fiberscopy with biopsies and/or bronchial brushing and/or BAL at the children's hospital of the Pellegrin Hospital or at the Haut Lévêque Hospital.
  • Having received or, for children whose holders of parental authority have received, an information note with the possibility of opposition in accordance with the MR004 (French law - Commission Nationale de l'Informatique et des Libertés (CNIL))

Exclusion Criteria:

  • Patient or holder of parental authority for children who have expressed their opposition to participation in the research

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Voluntario saludable
Perform brushing and/or bronchial biopsies and/or BAL and/or aspiration during bronchial fiberscopy and surgical waste during a lobectomy.
Patient with COPD
Perform brushing and/or bronchial biopsies and/or BAL and/or aspiration during bronchial fiberscopy and surgical waste during a lobectomy.
Sputum has been collected for biological analysis.
Blood sampling is the safe collection of a blood specimen from a vein, finger, or artery to run medical lab tests
Patient with Asthma
Perform brushing and/or bronchial biopsies and/or BAL and/or aspiration during bronchial fiberscopy and surgical waste during a lobectomy.
Sputum has been collected for biological analysis.
Blood sampling is the safe collection of a blood specimen from a vein, finger, or artery to run medical lab tests
Nasal brushing is a minimally invasive medical procedure used to collect cellular samples from the nasal lining by gently rubbing a small cytology brush against the mucosa.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Describe tobacco consumption
Periodo de tiempo: At enrollment
Number pack in years
At enrollment
Describe tobacco statut
Periodo de tiempo: At enrollment
Described as either non-smokers, former smokers or current smokers
At enrollment
Description of demographic status
Periodo de tiempo: At enrollment
Gender (male or female)
At enrollment
Description of demographic status
Periodo de tiempo: At enrollment
Age as years
At enrollment
Description of demographic status
Periodo de tiempo: At enrollment
Body Mass Index (BMI) (kg/m^2)
At enrollment
Mesure of lung function parameters
Periodo de tiempo: At enrollment
FEV1: forced expiratory volume in 1 sec
At enrollment
Mesure of lung function parameters
Periodo de tiempo: At enrollment
FVC: forced vital capacity
At enrollment
Mesure of lung function parameters
Periodo de tiempo: At enrollment
FEF25-75: forced expiratory flow between 25 and 75% of the FVC
At enrollment
Mesure of lung function parameters
Periodo de tiempo: At enrollment
TLC: total lung capacity
At enrollment
Mesure of lung function parameters
Periodo de tiempo: At enrollment
RV: residual volume
At enrollment
Describe of disease status
Periodo de tiempo: At enrollment
Described as Healthy, COPD or Asthma
At enrollment
Collection type
Periodo de tiempo: At enrollment
Described as bronchial or lung specimens (frozen of embedded in paraffin), bronchial smooth muscle cells, bronchial epithelial cells, alveolar cells, arterial smooth muscle cells, arterial endothelial cells, fibrocytes, mesenchymal cells, lymphocytes, neutrophils, macrophages, organoïds.
At enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mesure of blood gas parameter
Periodo de tiempo: At enrollment
PaO2: arterial pressure in oxygen,
At enrollment
Mesure of blood gas parameter
Periodo de tiempo: At enrollment
PaCO2: arterial pressure in carbon dioxide
At enrollment
Mesure of blood gas parameter
Periodo de tiempo: At enrollment
pH
At enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de agosto de 2026

Publicado por primera vez (Actual)

21 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The data is available from Pr BERGER . An email can be sent to him so that he can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.

Marco de tiempo para compartir IPD

End date

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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