Clinical trial NCT01692444: Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease
Official title: Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Fibrosis
Fibroblast
Lung attenuation
Pletysmography
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
timeFrame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Secondary outcomes:
measure: Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
timeFrame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
measure: Correlation between lung attenuation and the number of fibrocytes
timeFrame: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
measure: Correlation between plethysmography and the number of fibrocytes.
timeFrame: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
Other outcomes:
Locations:
city: Pessac
country: France
facility: University hospital of Bordeaux, Hôpital du Haut Lévêque
Study officials:
affiliation: University Hospital, Bordeaux
name: Nicholas MOORE, MD-PhD
role: STUDY_CHAIR
References:
citation: Henrot P, Beaufils F, Thumerel M, Eyraud E, Boudoussier A, Begueret H, Maurat E, Girodet PO, Marthan R, Berger P, Dupin I, Zysman M. Circulating fibrocytes as a new tool to predict lung cancer progression after surgery? Eur Respir J. 2021 Dec 9;58(6):2101221. doi: 10.1183/13993003.01221-2021. Print 2021 Dec. No abstract available.