- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07780630
Creation of a Biological Collection of BRonchiaI and Pulmonary Tissues From Surgical wastE (BRISE)
Přehled studie
Postavení
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
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Patrick BERGER, MD, PhD
- Telefonní číslo: +33 5 47 30 27 50
- E-mail: patrick.berger@u-bordeaux.fr
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
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
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
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
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Patologické procesy
- Chronické onemocnění
- Atributy nemoci
- Onemocnění imunitního systému
- Nemoci dýchacích cest
- Plicní onemocnění
- Bronchiální onemocnění
- Plicní onemocnění, obstrukční
- Respirační přecitlivělost
- Přecitlivělost, okamžitá
- Přecitlivělost
- Patologické stavy, příznaky a symptomy
- Plicní onemocnění, chronická obstrukční
- Astma
- Choroba
- Vyšetřovací techniky
- Manipulace se vzorkem
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Vpichy
- Chirurgické postupy, operativní
- Sběr vzorků krve
Další identifikační čísla studie
- CHUBX 2025/117
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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 .