Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01692444
First received: September 17, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.

The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects. [ Time Frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II [ Time Frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0) ] [ Designated as safety issue: No ]
  • Correlation between lung attenuation and the number of fibrocytes [ Time Frame: Assessed one year after inclusion visit (i.e. surgery date =Day 0) ] [ Designated as safety issue: No ]
  • Correlation between plethysmography and the number of fibrocytes. [ Time Frame: Assessed one year after inclusion visit (i.e. surgery date = Day 0) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Lung tissue form surgery such as lobectomy or pneumonectomy,whole blood sample for fibrocytes analysis


Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD
15 patients with COPD from 1 to 4 according to the GOLD 2011
Non smoker Control
15 patients without COPD and no smoking history
Smoker Control
15 patients without COPD but a smoking history

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Controls and COPD patients will be recruited during surgical visit or hospitalization in thoracic surgery department before surgery.

Criteria

Inclusion Criteria:

  • Male or female aged more than 40 yr
  • Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.
  • COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.
  • Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
  • with a written informed consent

Exclusion Criteria:

  • Subject without any social security or health insurance
  • Asthma, lung fibrosis or idiopathic pulmonary hypertension
  • Chronic viral infections (hepatitis, HIV)
  • Pregnant woman or breastfeeding
  • Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692444

Contacts
Contact: Matthieu THUMEREL, MD (0)557656009 ext +33 matthieu.thumerel@chu-bordeaux.fr

Locations
France
University hospital of Bordeaux, Hôpital du Haut Lévêque Recruiting
Pessac, France, 33604
Contact: Matthieu THUMEREL, MD    (0)557656009 ext +33    matthieu.thumerel@chu-bordeaux.fr   
Principal Investigator: Matthieu THUMEREL, MD         
Sub-Investigator: Hugues BEGUERET, MD-PhD         
Sub-Investigator: Michel MONTAUDON, MD-PhD         
Sub-Investigator: Patrick BERGER, MD-PhD         
Sub-Investigator: Annaig OZIER, MD-PhD         
Sub-Investigator: Roger MARTAN, MD-PhD         
Sub-Investigator: Pierre-Olivier GIRODET, MD-PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Nicholas MOORE, MD-PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01692444     History of Changes
Other Study ID Numbers: CHUBX 2011/34
Study First Received: September 17, 2012
Last Updated: May 9, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Chronic Obstructive Pulmonary Disease
Fibrosis
Fibroblast
Lung attenuation
Pletysmography

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014