The Canadian Cohort Obstructive Lung Disease (CanCOLD)
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Purpose
Abstract Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in Canada. COPD is not just a disease of men, nor is it solely a disease in old age. Women have been underrepresented and early disease has not been studied. Underdiagnosis of COPD remains a significant problem, and it may indicate an unmet healthcare need. This can potentially results not only in a patient been misinformed, but can lead to incorrect management.
Epidemiological research is needed to develop a framework to combat this major health problem, by better characterization of the population of men and women at risk and patients with early disease, by better understanding which factors modifiable through health interventions are related to health perception (health-related quality of life) and disease evolution.
This will be possible through a nationwide study, the Canadian Cohort Obstructive Lung disease (CanCOLD), a prospective longitudinal study. The CanCOLD study is built on the current ongoing prevalence nationwide study, the Canadian Obstructive Lung disease "COLD" study.
The CanCOLD will be the first study to assess prevalence of disease across Canada and its consequence in men and women, and to evaluate a conceptual model of disease severity based on patient's health perception (health-related quality of life). Ultimately, this project will extend to a longitudinal follow up (5 years or beyond) and will allow to have a better understanding of the lifestyle risk factors, not only smoking but also diet, physical activity, and co morbid conditions. This will be a great asset to shift from management of a single risk factor (tobacco control) to total COPD risk management. The results of the study will greatly help to assist decision makers in developing policies to improve the diagnosis, the management of COPD and to optimize health care services use.
| Condition |
|---|
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COPD Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Canadian Cohort Obstructive Lung Disease |
- CanCOLD aims to be the first study to characterize COPD among a random sample of Canadians using spirometry as one of the main outcome. [ Time Frame: One visit a year ] [ Designated as safety issue: No ]
- To estimate the relationship between structural/biological and physiological variables and symptoms, functional status, comorbid conditions and perception of health. [ Time Frame: One visit a year ] [ Designated as safety issue: No ]
- To compare the relationship among models variables between individuals with COPD and their non-COPD peers (those at risk and health peers). [ Time Frame: One visit a year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood sampling
- Biomarkers:IL-6, CRP, CC-16, SP-D"
- DNA for genetics, epigenetic and RNA for transcriptomics
- Markers for cardiovascular diseases: LDL, LDL and HDL sizes, Apo B, Apo A1, CRP, IL6, TNF alpha, Adiponectine, Leptine, Glucose and Insulin.
| Estimated Enrollment: | 1600 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1 male
Male subjects with airflow obstruction (post-bronchodilator FEV1/FVC<0.70): COPD moderate-severe (GOLD 2-4) (post-BD FEV1 <80% of predicted value)
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Group 2 male
Male subjects with mild COPD or early disease (post-BD FEV1 ≥80% of predicted value) (GOLD 1)
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Group 3 male
Male subjects at risk of COPD (smoker with post-BD FEV1/FVC≥0.70)
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Group 4 male
Male subjects non smokers "Respiratory disease free control" (pre- and post-BD FEV1/FVC≥0.70).
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|
Group 1 female
Female subjects with airflow obstruction (post-bronchodilator FEV1/FVC<0.70): COPD moderate-severe (GOLD 2-4) (post-BD FEV1 <80% of predicted value)
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Group 2 female
Female subjects with mild COPD or early disease (post-BD FEV1 ≥80% of predicted value) (GOLD 1)
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Group 3 female
Female subjects at risk of COPD (smoker with post-BD FEV1/FVC≥0.70)
|
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Group 4 female
Female subjects non smokers "Respiratory disease free control" (pre- and post-BD FEV1/FVC≥0.70).
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects' selection and participation in CanCOLD- longitudinal cohort: Subjects will be recruited from the study site participants (total from cross-sectional ≈5,000 subjects, men and women).
Inclusion Criteria:
- All the subjects have taken part in the COLD study, a true population based prevalence study.
Contacts and Locations| Contact: Sarah Bernard, M.Sc. | 418-656-8711 ext 3617 | sarah.bernard@criucpq.ulaval.ca |
| Contact: Jean Bourbeau, M.D., M.Sc. | 514-934-1934 ext 32158 | jean.bourbeau@mcgill.ca |
| Canada, Alberta | |
| Health Sciences Centre | Active, not recruiting |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Canada, British Columbia | |
| St-Paul's Hospital | Active, not recruiting |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Nova Scotia | |
| Halifax Infirmary | Active, not recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Kingston General Hospital | Not yet recruiting |
| Kingston, Ontario, Canada, K7L 2V6 | |
| Contact: Kathy Webb kathy.webb@queensu.ca | |
| Sub-Investigator: Denis O'Donnell, M.D. | |
| Ottawa Hospital General | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Kathy Vandemheen (613) 737-8259 kvandemheen@ohri.ca | |
| Sub-Investigator: Shawn Aaron, M.D., M.Sc. | |
| University of Toronto | Active, not recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Montreal Chest Institute | Active, not recruiting |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Canada, Saskatchewan | |
| Royal University Hospital | Not yet recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Contact: Darcy Marciniuk, M.D. (306) 966-8298 darcy.marciniuk@usask.ca | |
| Sub-Investigator: Darcy Marciniuk, M.D. | |
| Canada | |
| Institut universitaire de cardiologie et de pneumologie de Québec | Not yet recruiting |
| Quebec, Canada, G1V 4G5 | |
| Contact: Marie-Josée Breton (418) 656-8711 ext 5823 marie-josee.breton@criucpq.ulaval.ca | |
| Sub-Investigator: François Maltais, M.D. | |
| Principal Investigator: | Jean Bourbeau, M.D., M.Sc. | McGill University Health Center |
| Principal Investigator: | Wan Tan, M.D. | CAAA University of British Columbia |
| Principal Investigator: | François Maltais, M.D. | CFBA Université Laval |
| Principal Investigator: | Shawn Aaron, M.D., M.Sc. | OHGC Ottawa Hospital General Campus |
| Principal Investigator: | Denis O'Donnell, M.D. | CEDA Queen's University (Kinsgston) |
| Principal Investigator: | Darcy D Marciniuk, M.D. | CCAA University of Saskatchewan |
| Principal Investigator: | Robert Cowie, M.D. | CBBA University of Calgary |
| Principal Investigator: | Kenneth R. Chapman, M.D., M.Sc. | CEAA University of Toronto |
| Principal Investigator: | Paul Hernandez, M.D. | CHAA Dalhousie University (Nova Scotia) |
| Principal Investigator: | Mark J. FitzGerald, M.D. | CAAA University of British Columbia |
| Principal Investigator: | Donald Sin, M.D. | CAAA University of British Columbia |
| Principal Investigator: | Andrea Benedetti, Ph.D. | INUD McGill University Healty Center |
| Principal Investigator: | Yves Lacasse, M.D., M.Sc. | CPVR Institut universitaire de cardiologie et de pneumologie de Québec |
| Principal Investigator: | Pierre Ernst, M.D. | McGill University |
| Principal Investigator: | Harvey Coxson, M.D. | University of British Columbia |
| Principal Investigator: | Roger Goldstein, M.D. | CEAA University of Toronto |
| Principal Investigator: | Carlo Marra, Ph.D. | CAAA University of British Columbia |
More Information
No publications provided
| Responsible Party: | Jean Bourbeau MD, M.Sc., Research Institute of the McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT00920348 History of Changes |
| Other Study ID Numbers: | IRO-93326 |
| Study First Received: | June 12, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McGill University:
|
Chronic obstructive pulmonary disease COPD Cohort study prospective longitudinal study tissue bank |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013