Trial record 11 of 962 for:
Open Studies | "Lung Diseases, Obstructive"
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)
This study is not yet open for participant recruitment.
Verified April 2013 by University Hospital, Bordeaux
Sponsor:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01692444
First received: September 17, 2012
Last updated: April 18, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | May 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (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
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 | Not yet 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: | April 18, 2013 |
| Health Authority: | France: L’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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013