Clinical trial NCT03240198: Biological Markers for Professional COPD
Official title: Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Copd
Keywords: occupational
cohort
biomarkers
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: University Hospital, Bordeaux
name: University Hospital, Caen
name: University Hospital, Lille
name: Centre Hospitalier Le Havre
name: Henri Mondor University Hospital
First posted: 2017-08-07
Enrollment: 400
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD and healthy subjects exposed to tobacco smoking and/or to occupational dust

Brief 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.


Eligibility criteria: Inclusion Criteria:

* COPD

Exclusion Criteria:

* Other obstructive disease

Primary outcomes:
measure: C Protein Reactive
timeFrame: at year 1
measure: blood inflammatory markers
timeFrame: at year 1
Secondary outcomes:
measure: C Protein Reactive
timeFrame: every year during 5 years
measure: blood inflammatory markers
timeFrame: every year during 5 years
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
Study officials:
References: