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

19. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

650

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

      • Pessac, Francie, 33604
        • CHU de Bordeaux
        • Vrchní vyšetřovatel:
          • Patrick BERGER, MD, PhD
        • Kontakt:
          • Patrick BERGER, PUPH
          • Telefonní číslo: (+33)05 57 65 65 13

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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).

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Zdravý dobrovolník
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Describe tobacco consumption
Časové okno: At enrollment
Number pack in years
At enrollment
Describe tobacco statut
Časové okno: At enrollment
Described as either non-smokers, former smokers or current smokers
At enrollment
Description of demographic status
Časové okno: At enrollment
Gender (male or female)
At enrollment
Description of demographic status
Časové okno: At enrollment
Age as years
At enrollment
Description of demographic status
Časové okno: At enrollment
Body Mass Index (BMI) (kg/m^2)
At enrollment
Mesure of lung function parameters
Časové okno: At enrollment
FEV1: forced expiratory volume in 1 sec
At enrollment
Mesure of lung function parameters
Časové okno: At enrollment
FVC: forced vital capacity
At enrollment
Mesure of lung function parameters
Časové okno: At enrollment
FEF25-75: forced expiratory flow between 25 and 75% of the FVC
At enrollment
Mesure of lung function parameters
Časové okno: At enrollment
TLC: total lung capacity
At enrollment
Mesure of lung function parameters
Časové okno: At enrollment
RV: residual volume
At enrollment
Describe of disease status
Časové okno: At enrollment
Described as Healthy, COPD or Asthma
At enrollment
Collection type
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mesure of blood gas parameter
Časové okno: At enrollment
PaO2: arterial pressure in oxygen,
At enrollment
Mesure of blood gas parameter
Časové okno: At enrollment
PaCO2: arterial pressure in carbon dioxide
At enrollment
Mesure of blood gas parameter
Časové okno: At enrollment
pH
At enrollment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

12. června 2026

První předloženo, které splnilo kritéria kontroly kvality

19. srpna 2026

První zveřejněno (Aktuální)

21. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • CHUBX 2025/117

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

End date

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .