Biological Markers for Professional COPD

NCT03240198 | Unknown

• 1 other identifier: MB2PROF
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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. 1.To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,
2. 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. 3.To identify biological phenotypes of COPD associated to a given etiological agent.
4. 4.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.
5. 5.The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD,
6. 6.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.

Conditions

Copd

Keywords

occupational; cohort; biomarkers

Outcome Measures

Primary Outcomes (2)

• C Protein Reactive

  at year 1

• blood inflammatory markers

  at year 1

Secondary Outcomes (2)

• C Protein Reactive

  every year during 5 years

• blood inflammatory markers

  every year during 5 years

Study Arms (2)

COPD

Controls

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD and healthy subjects exposed to tobacco smoking and/or to occupational dust

You may qualify if:

• COPD

You may not qualify if:

• Other obstructive disease

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Centre Hospitalier Universitaire de Besancon: collaborator
• University Hospital, Bordeaux: collaborator
• University Hospital, Caen: collaborator
• University Hospital, Lille: collaborator
• Centre Hospitalier Le Havre: collaborator
• Henri Mondor University Hospital: collaborator

Study Sites (1)

CHI Créteil

Créteil, 94000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: August 7, 2017
• Study Start: January 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2021
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

FR (1)