Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)
5. juni 2026 opdateret af: University Hospital, Bordeaux
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pessac, Frankrig, 33604
- University hospital of Bordeaux, Hôpital du Haut Lévêque
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Studiebefolkning
Controls and COPD patients will be recruited during surgical visit or hospitalization in thoracic surgery department before surgery.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Nicholas MOORE, MD-PhD, University Hospital, Bordeaux
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. april 2013
Primær færdiggørelse (Faktiske)
20. maj 2016
Studieafslutning (Faktiske)
20. maj 2016
Datoer for studieregistrering
Først indsendt
17. september 2012
Først indsendt, der opfyldte QC-kriterier
20. september 2012
Først opslået (Anslået)
25. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2026
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHUBX 2011/34
- 2012-A00571-42 (Anden identifikator: ANSM)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .