- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03240198
Biological Markers for Professional COPD (MB2PROF)
Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles
Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate with modification of protease-antiprotease and oxidant-antioxydant balances. Local modifications are associated with systemic changes. Many occupational factors have been associated with an excess of COPD in epidemiological studies, however without identification of any specific clinical or biological phenotype.
Pathophysiological pathways involved in COPD might be different according to etiologic agents. Therefore, it is important to focus research on blood biomarkers associated with some well-characterized occupational COPD.
The objectives of MB2PROF project are:
- To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,
- To study the evolution of clinical and lung function parameters of occupational COPD in comparison with non occupational COPD during a follow-up study,
- To identify biological phenotypes of COPD associated to a given etiological agent.
The methodology includes:
The constitution of a cohort with a clinical and biological follow-up during 5 years. Subjects will be recruited in 7 occupational diseases departments, with the collaboration of Pneumology departments.
Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60 subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical data, lung function parameters, occupation history and blood samples will be collected.
- The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD,
- The study of molecular pathways identified in these subgroups, with in vitro and in vivo studies The MB2PROF project is an original and ambitious multidisciplinary and translational project. The constitution of well-characterized COPD cases cohort should allow the identification of biomarkers and molecular pathways associated with some subgroup of subjects, and improve the knowledge of mechanisms involved.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Créteil, Frankrijk, 94000
- Werving
- Chi Creteil
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Contact:
- Pascal Andujar, MD PhD
- Telefoonnummer: 33 1 57 02 20 95
- E-mail: pascal.andujar@chicreteil.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- COPD
Exclusion Criteria:
- Other obstructive disease
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Controles
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COPD
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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C Protein Reactive
Tijdsspanne: at year 1
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at year 1
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blood inflammatory markers
Tijdsspanne: at year 1
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at year 1
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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C Protein Reactive
Tijdsspanne: every year during 5 years
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every year during 5 years
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blood inflammatory markers
Tijdsspanne: every year during 5 years
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every year during 5 years
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MB2PROF
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Klinische onderzoeken op Copd
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University Medical Center GroningenVoltooid
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Ryme Medical, Inc.Nog niet aan het wervenCOPD | Longziekte, chronisch obstructief | COPD-patiënten | COPD acute exacerbatie | COPD (chronische obstructieve longziekte) | Longziekte Luchtwegen | COPD-exacerbaties
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Insel Gruppe AG, University Hospital BernUniversity Hospital, Geneva; Cantonal Hospital St. Gallen, SwitzerlandNog niet aan het werven
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Istituto Nazionale di Ricovero e Cura per AnzianiWerving
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Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Werving
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Sir Run Run Shaw HospitalWerving
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The First Affiliated Hospital of Guangzhou Medical...Werving
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Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Werving
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Polytechnic Institute of PortoNippon Gases PortugalWerving
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China-Japan Friendship HospitalNog niet aan het werven