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

19. august 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

650

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Pessac, Frankrike, 33604
        • CHU de Bordeaux
        • Hovedetterforsker:
          • Patrick BERGER, MD, PhD
        • Ta kontakt med:
          • Patrick BERGER, PUPH
          • Telefonnummer: (+33)05 57 65 65 13

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Frisk frivillig
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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mesure of blood gas parameter
Tidsramme: At enrollment
PaO2: arterial pressure in oxygen,
At enrollment
Mesure of blood gas parameter
Tidsramme: At enrollment
PaCO2: arterial pressure in carbon dioxide
At enrollment
Mesure of blood gas parameter
Tidsramme: At enrollment
pH
At enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

19. august 2026

Først lagt ut (Faktiske)

21. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

End date

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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