Biological Markers for Professional COPD (MB2PROF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03240198|
Recruitment Status : Unknown
Verified August 2017 by Pascal ANDUJAR, Centre Hospitalier Intercommunal Creteil.
Recruitment status was: Recruiting
First Posted : August 7, 2017
Last Update Posted : August 30, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2021|
- C Protein Reactive [ Time Frame: at year 1 ]
- blood inflammatory markers [ Time Frame: at year 1 ]
- C Protein Reactive [ Time Frame: every year during 5 years ]
- blood inflammatory markers [ Time Frame: every year during 5 years ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Other obstructive disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240198
|Créteil, France, 94000|
|Contact: Pascal Andujar, MD PhD 33 1 57 02 20 95 email@example.com|
|Responsible Party:||Pascal ANDUJAR, Principal Investigator, Centre Hospitalier Intercommunal Creteil|
|Other Study ID Numbers:||
|First Posted:||August 7, 2017 Key Record Dates|
|Last Update Posted:||August 30, 2017|
|Last Verified:||August 2017|