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===Typical Studies===
===Typical Studies===
Typical studies include population-based [[longitudinal studies]]. Researchers may try to evaluate the contribution of a particular lifestyle or environmental factor and a chosen [[endophenotype]], or locate the gene regions associated with that endophenotype.
Typical studies include population-based [[longitudinal studies]]. Researchers may try to evaluate the contribution of a particular lifestyle, environmental and genetic factor and a chosen [[endophenotype]]. The use of endophenotypes facilitates the integration of multiple levels of data painting a more realistic portrait of gene-environment interactions influencing particular endophenotypes<ref name="Youssefs, frontiers 2012">{{cite journal|last=Idaghdour|first=Youssef|coauthors=Philip Awadalla|title=Exploting gene expression variation to capture gene-environment interactions for disease|journal=Frontiers in Statistical Genetics and Methodology|date=2012|year=2012|month=October|volume=3|issue=228|doi=doi: 10.3389/fgene.2012.00228|accessdate=8 April 2013}}</ref>


== Development ==
== Development ==

Revision as of 15:15, 8 April 2013

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The CARTaGENE project is a population based Biobank and the largest ongoing and long-term health study of men and women in Québec. The project's core mandate is to identify the genetic and environmental causes of common chronic diseases affecting the Québec population. The overall objective from a public health perspective is to develop personalized medicine and public policy initiatives targeting high risk groups[1] . The project is under the scientific leadership of Executive Scientific Director Dr. Philip Awadalla, a geneticist at the Sainte-Justine Mother-Child Hospital University Health Center Centre hospitalier universitaire Sainte-Justine and professor at the Université de Montréal. Prof. Guy Rouleau, Director of the Montreal Neurological Institute at McGill University is the Co-Principal Investigator. Dr. Pavel Hamet, a Professor at the CHUM of the University of Montreal is the Medical Director. Based in Montréal Québec, Canada, CARTaGENE is operated under the infrastructure of the Sainte-Justine Children’s Hospital University Health Center and has seen funding from Genome Canada, the Canadian Foundation for Innovation and Génome Québec[2] and the Canadian Partnership Against Cancer (CPAC) since 2007 among other sources[1] .

Design

The CARTaGENE project consists of recruiting men and women aged 40-69 years old from Québec representing an age range most at risk for developing chronic diseases, including cardiovascular disease, metabolic disorders like diabetes mellitus and cancer among others[1] . Taking place between August 2009 and October 2010, 20 007 participants were enrolled in its first phase of recruitment (Phase A)[3] . A new wave of recruitment (Phase B) will enroll an additional 17 000 participants by March 2013[1] . The participants are randomly selected and tracked based on their files in the governmental health administrative databases (RAMQ-Régie de l’Assurance Maladie du Québec) [4] . Participants were also selected to be representative of 1% of the metropolitan areas of Québec, specifically Montreal, Québec city, Sherbrooke and the Saguenay[5] . Because of administrative linkage between the RAMQ and the CHU Sainte-Justine, participants can be passively followed for the next 50 years making it one of the longest and largest ongoing population studies in the world[6]. Information packages about the project were first sent by mail and potential participants were contacted by telephone to enroll and schedule visits to one of the clinical assessment sites[7] . A total of 12 assessment sites across the province were established for clinical and physical assessments[8]. Following initial phone contact, participants were invited to come to the assessment site and sign a consent form[9] . They were asked to complete a self-administered wikt:socio-demographic and lifestyle questionnaire and an interviewer-administered health questionnaire[10]. A genealogical questionnaire was also included[11] for completion online. Non-invasive measurements were taken for all participants that included basic measurements such as weight, height, blood pressure[12]. Blood, saliva and urine were collected and preserved at the Biobanque Génome Québec and the affiliated University Hospital Center in Chicoutimi (Biobanque GQ-CAURC[13]) for future use[14]. Surveys about nutrition[1] are also included and residential information, occupational history and food frequency data questionnaires are administered[1]. Moreover, CARTaGENE is part of a Canada-wide cohort collecting samples across the country whose methods were applied in the design of the five cohorts within the Canadian Partnership for Tomorrow Project[15] (CPTP)[16]

Molecular Profiling

We obtained detailed clinical chemistry and complete blood counts for each of the participants[17]. Specifically, we collected detailed lipid profiles, Hba1c, creatinine and many others[18]. Blood collection was undertaken such that DNA and RNA could be extracted for future use[19]. This makes the study of proteomics and lipidomics on a large-scale possible. The CARTaGENE project has a full-scale Systems Genomics program to identify critical events associated with a number of cardiovascular related endophenotypes. Participant medical history is maintained at a centralized governmental database (RAMQ) allowing researchers to track these individuals for the duration of the study and monitor all medical events, prescriptions of drugs and deaths[1]. The personal information connecting the medical information to the patient identification is depersonalized and coded by CARTaGENE, but handled and managed by the RAMQ ensuring patient confidentiality[1] .

To access the database, researchers must submit an application and undergo evaluation by an independent Sample and Data Access Committee (SDAC)[1] .

Typical Studies

Typical studies include population-based longitudinal studies. Researchers may try to evaluate the contribution of a particular lifestyle, environmental and genetic factor and a chosen endophenotype. The use of endophenotypes facilitates the integration of multiple levels of data painting a more realistic portrait of gene-environment interactions influencing particular endophenotypes[20]

Development

There was an initial pilot study done under the direction of Professor Bartha Knoppers (McGill University) and Professor Claude Laberge (Laval University) that involved 223 participants who responded to a questionnaire based on the P3G DataSHaPER[21] model. The scales used in the questionnaires were developed and revised by more than 30 experts from various fields and are widely used[22]. These included the Patient Health questionnaire[23], the General Anxiety Scale[23], the Job Content[24] and International Physical Activity Questionnaire IPAQ.

Initial Information collected

  • Signed consent form
  • Genealogical questionnaire: self-administered
  • Health questionnaire: administered by interviewer at clinical sites included socio-demographic factors, lifestyle, mental state, psychosocial environment, personal and family history of disease, health care use and reproductive health and history.
  • Declared health conditions: diagnosis required by a physician.
  • Socio-demographic and lifestyle questionnaire: self-administered
  • Contra-indication questionnaire

Measurements

Biochemical and Haemotological analysis

Haematological and biochemical assessements were done immediately following collection. A complete list of clinical measurements is described in[25] .

Biobanking

A total of 106.5 ml of blood was collected in Vacutainers from each participant and was split for various tests and storage. Half of the samples are stored in a "mirror site" with the same quality and safety standards as the primary sites to ensure safety[26].

Ethics and Governance

CARTaGENE complies with all applicable laws, including:

CARTaGENE also complies with all applicable ethical norms, including:

Finally, CARTaGENE also complies with the following recommendations:

  • Plan d’action ministériel en éthique de la recherche et en intégrité scientifique from the MSSS (1998)[35]
  • Guide d’élaboration de normes de gestion des banques de données also from the MSSS (2004)[36]
  • Document de gestion des banques de données constituées ou utilisées pour des fins de recherche (2006)[37] and the Politique de la recherche avec des êtres humains (2004)[38]

Legal monitoring

CARTaGENE is monitored by the Research Ethics Board of the Sainte-Justine University Health Center[1] . It is also under the supervision of the Information Access Commission (the Commission d'accès à l'information du Québec, CAI[39] ). This organization authorizes the transfer of information from the RAMQ to the call center that contacts participants and all personal information held by CARTaGENE is subject to surveillance by the CAI[1] .

Access

The dataset is available to researchers in industry and academic institutions, nationally and internationally. Applications detailing their project proposal are required and will be reviewed by an independent committee, the Sample and Data Access Committee (SDAC)[1]. The scientific management of CARTaGENE along with the SDAC determines if data or results should need to be returned to the project. Submission for access to the dataset is done directly online[40].

Recruitment and reassessment

The CARTaGENE project has enrolled an additional 17 000 participants in the project [1]. This recruitment is currently underway across the province of Quebec[1].

Opinion and Media

The public was generally receptive to the creation of the CARTaGENE project and an independent study reported on the consultations held with members of the public[41]. The main concerns raised were about safeguarding medical records and confidentiality, respect for individual transparency, the donor's right to feedback and governance [41].

Media

Local and national media have reported on CARTaGENE.

Print media

  • La Presse/La Presse Canadienne, Lia Levesque (15 Janvier 2013) « Un ratio «inquiétant» de Québécois ont une maladie chronique à leur insu »[42]
  • Le Soleil,  Jean François Cliche (15 janvier 2013) « Projet Cartagène: jusqu'à un Québécois sur deux malade sans le savoir »[43]
  • Le Droit/La Presse Canadienne, Lia Levesque (Janvier 2013) «Des Québécois atteints de maladies chroniques sans le savoir »[44]
  • La Tribune/La Presse Canadienne, Lia Levesque (14 Janvier 2013) «Des Québécois atteints de maladies chroniques sans le savoir »[45]
  • Le Devoir, Pauline Gravel (15 janvier 2013) « Cartagène commence à porter ses fruits »[46]
  • The Gazette, Charlie Fidelman (15 janvier 2013) « Quebec's CARTaGene genetic study shows "huge portion" of population unaware of chronic diseases»[47]
  • Ottawa Citizen, Charlie Fidelman (15 janvier 2013) « Quebec's CARTaGene genetic study shows "huge portion" of population unaware of chronic diseases»[47]
  • Le Devoir, Pauline Gravel (18 janvier 2013) « Données génétiques - La biobanque Cartagène est hautement sécurisée »[48]

Television

  • Radio-Canada TV, Catherine Kovacks (14 janvier 2013) « Cartagène à la recherche de volontaires »[49]
  • CBC News Montreal Late, Nancy Woods  (14 janvier 2013) Montreal Late 12:28[50]

Harmonization with International cohorts

CARTaGENE has been designed such that its infrastructure including collecting samples, measuring biological variables and the storage procedures can be harmonized with other international large-scale cohorts via the Public Population Project in Genomics (P3G) platform. The P3G facilitates the work of biobankers and improves collaboration throughout the international human genomics research community [51]. A nationwide effort is underway to collect samples from participants across Canada, with CaG representing one of five cohorts within the Canadian Partnership for Tomorrow (CPTP)[52]. CPTP is recruiting 300 000 participants to create a national databank on population health whose core mandate is to develop strategic initiatives leading to policy change to address the growing impact of chronic disease in a growing Canadian population.[53]

References

  1. ^ a b c d e f g h i j k l m n "Cartagene". cartagene.qc.ca. Retrieved 3 April 2013.
  2. ^ www.genomequebec.com/
  3. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  4. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  5. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  6. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  7. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  8. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  9. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  10. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  11. ^ Quebec Reference Sample Population Genetics and Genetic Epidemiology in Quebec: BALSAC, http://www.quebecgenpop.ca/BALfichier_en.html
  12. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  13. ^ http://www.genomequebec.com/en/gq-caurc-bionbank.html
  14. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  15. ^ www.partnershipfortomorrow.ca
  16. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  17. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  18. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  19. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  20. ^ Idaghdour, Youssef (2012). "Exploting gene expression variation to capture gene-environment interactions for disease". Frontiers in Statistical Genetics and Methodology. 3 (228). doi:doi: 10.3389/fgene.2012.00228. {{cite journal}}: |access-date= requires |url= (help); Check |doi= value (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)CS1 maint: date and year (link)
  21. ^ http://www.datashaper.org/
  22. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  23. ^ a b Spitzer, R. L., Kroenke, K. & Williams, J. B. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA : the journal of the American Medical Association 282, 1737-1744 (1999). Cite error: The named reference "spitzer" was defined multiple times with different content (see the help page).
  24. ^ Karasek, R. et al. The Job Content Questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. Journal of occupational health psychology 3, 322-355 (1998).
  25. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  26. ^ Awadalla, Philip (october 15). "Cohort profile of the CARTaGENE study: Quebec's population-based biobank for public health and personalized genomics" (PDF). International Journal of Epidemiology: 2. doi:10.1093/ije/dys160. Retrieved 3 April 2013. {{cite journal}}: Check date values in: |date= and |year= / |date= mismatch (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |month= ignored (help)
  27. ^ http://www.protecteurducitoyen.qc.ca/fileadmin/medias/pdf/1.4.5-_AN_ACT_RESPECTING_HEALTH_SERVICES_AND_SOCIAL_SERVICES.pdf
  28. ^ http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/A_2_1/A2_1_A.html
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  32. ^ http://www.frsq.gouv.qc.ca/fr/ethique/pdfs_ethique/Sommaire_groupe_conseil_francais.pdf
  33. ^ "International Declaration on Human and Genetic data". www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genetic-data/. http://unesdoc.unesco.org/images/0013/001331/133171e.pdf#page=45: Unesco. 2003. Retrieved 3 April 2013. {{cite web}}: External link in |location= (help)CS1 maint: location (link)
  34. ^ "Universal Declaration on Bioethics and Human Rights". www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights. http://unesdoc.unesco.org/images/0014/001461/146180E.pdf. 2006. Retrieved 3 April 2013. {{cite web}}: External link in |location= (help)CS1 maint: location (link)
  35. ^ "Plan d'action ministériel en éthique de la recherche et en intégrité scientifique". ethique.msss.gouv.qc.ca. http://ethique.msss.gouv.qc.ca/site/download.php?c6d3e3200feeca4c50623083af406127: msss. 1998. {{cite web}}: |access-date= requires |url= (help); External link in |location= (help); Missing or empty |url= (help)CS1 maint: location (link)
  36. ^ "Guide de normes de gestion des banques de données". msss.gouv.qc.ca. http://publications.msss.gouv.qc.ca/acrobat/f/documentation/2012/12-727-02W.pdf: MSSS. {{cite web}}: |access-date= requires |url= (help); External link in |location= (help); Missing or empty |url= (help)CS1 maint: location (link)
  37. ^ "Document de gestion des banques de données constituées ou utilisées pour des fins de recherche". secretariatgeneral.umontreal.ca. http://secretariatgeneral.umontreal.ca/fileadmin/user_upload/secretariat/Renseignements_personnels/Gestion0BDD_01.pdf: umontreal. Retrieved 3 April 2013. {{cite web}}: External link in |location= (help)CS1 maint: location (link)
  38. ^ "Éthique de la recherche avec des êtres humains". ethique.gc.ca. http://ethique.gc.ca/pdf/fra/eptc2/EPTC_2_FINALE_Web.pdf: Gouvernement du Québec. Retrieved 3 April 2013. {{cite web}}: External link in |location= (help)CS1 maint: location (link)
  39. ^ "Commission d'accès à l'information du Québec". www.cai.gouv.qc.ca. Retrieved 8 April 2013.
  40. ^ CARTaGENE, http://www.cartagene.qc.ca
  41. ^ a b Godard, B., Marshall, J. & Laberge, C. Community engagement in genetic research: results of the first public consultation for the Quebec CARTaGENE project. Community genetics 10, 147-158, doi:10.1159/000101756 (2007).
  42. ^ Levesque, L. http://www.lapresse.ca (La Presse, http://www.lapresse.ca, 2013).
  43. ^ Cliche, J. F. in Le Soleil http://www.lapresse.ca (2013).
  44. ^ Levesque, L. http://www.lapresse.ca (La Presse, LeDroit, 2013).
  45. ^ Levesque, L. in La Tribune http://www.lapresse.ca (La Presse,http:// www.lapresse.ca, 2013).
  46. ^ Gravel, P. in Le Devoir (Le Devoir, http://www.LeDevoir.com, 2013).
  47. ^ a b Fidelman, C. (The Montreal Gazette, 2013).
  48. ^ Gravel, P. in Le Devoir (2013).
  49. ^ Radio-Canada.ca, T. (Radio-Canada, 2013).
  50. ^ CBC News: Montreal Late Night http://www.cbc.ca/player/News/Canada/Montreal/ID/2325600354/ (2013).
  51. ^ Fortin, S., Pathmasiri, S., Grintuch, R. & Deschenes, M. 'Access arrangements' for biobanks: a fine line between facilitating and hindering collaboration. Public Health genomics 14, 104-114, doi:10.1159/000309852 (2011).
  52. ^ Borugian, M. J. et al. The Canadian Partnership for Tomorrow Project: building a pan-Canadian research platform for disease prevention. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 182, 1197-1201, doi:10.1503/cmaj.091540 (2010).
  53. ^ Borugian, M. J. et al. The Canadian Partnership for Tomorrow Project: building a pan-Canadian research platform for disease prevention. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 182, 1197-1201, doi:10.1503/cmaj.091540 (2010).
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