Biological Markers for Professional COPD

Copd Clinical Trial

— MB2PROF  

Official title:

Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240198
• Other study ID #: MB2PROF
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: August 29, 2017
• Start date: January 2010
• Est. completion date: January 2021

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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:

1. To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,

2. To study the evolution of clinical and lung function parameters of occupational COPD in comparison with non occupational COPD during a follow-up study,

3. To identify biological phenotypes of COPD associated to a given etiological agent.

The methodology includes:

1. 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.

2. The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD,

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2021
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD

Exclusion Criteria:

• Other obstructive disease

Related Conditions & MeSH terms

• Copd

Locations

Country	Name	City	State
France	CHI Créteil	Créteil

Sponsors (7)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Centre Hospitalier Le Havre, Centre Hospitalier Universitaire de Besancon, Henri Mondor University Hospital, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C Protein Reactive		at year 1
Primary	blood inflammatory markers		at year 1
Secondary	C Protein Reactive		every year during 5 years
Secondary	blood inflammatory markers		every year during 5 years