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

19. August 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

650

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

      • Pessac, Frankreich, 33604
        • CHU de Bordeaux
        • Hauptermittler:
          • Patrick BERGER, MD, PhD
        • Kontakt:
          • Patrick BERGER, PUPH
          • Telefonnummer: (+33)05 57 65 65 13

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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).

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Gesunder Freiwilliger
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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mesure of blood gas parameter
Zeitfenster: At enrollment
PaO2: arterial pressure in oxygen,
At enrollment
Mesure of blood gas parameter
Zeitfenster: At enrollment
PaCO2: arterial pressure in carbon dioxide
At enrollment
Mesure of blood gas parameter
Zeitfenster: At enrollment
pH
At enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

12. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

End date

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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