- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01692444
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Pessac, Frankrike, 33604
- University hospital of Bordeaux, Hôpital du Haut Lévêque
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: COPD
15 patients with COPD from 1 to 4 according to the GOLD 2011
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analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
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Placebo-jämförare: Non smoker Control
15 patients without COPD and no smoking history
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analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
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Aktiv komparator: Smoker Control
15 patients without COPD but a smoking history
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analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
Tidsram: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
Tidsram: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
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Correlation between lung attenuation and the number of fibrocytes
Tidsram: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Correlation between plethysmography and the number of fibrocytes.
Tidsram: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Nicholas MOORE, MD-PhD, University Hospital, Bordeaux
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Dupin I, Thumerel M, Maurat E, Coste F, Eyraud E, Begueret H, Trian T, Montaudon M, Marthan R, Girodet PO, Berger P. Fibrocyte accumulation in the airway walls of COPD patients. Eur Respir J. 2019 Sep 5;54(3):1802173. doi: 10.1183/13993003.02173-2018. Print 2019 Sep.
- Eyraud E, Maurat E, Sac-Epee JM, Henrot P, Zysman M, Esteves P, Trian T, Dupuy JW, Leipold A, Saliba AE, Begueret H, Girodet PO, Thumerel M, Hustache-Castaing R, Marthan R, Levet F, Vallois P, Contin-Bordes C, Berger P, Dupin I. Short-range interactions between fibrocytes and CD8+ T cells in COPD bronchial inflammatory response. Elife. 2023 Jul 26;12:RP85875. doi: 10.7554/eLife.85875.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUBX 2011/34
- 2012-A00571-42 (Annan identifierare: ANSM)
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