| Name | Estonian Genome Center of University of Tartu |
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| Acronym | EGC |
| Last update | 02/19/2010 |
Principal investigator
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Andres Metspalu (Population-based biobanks /Prof.)
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EGP, University of Tartu |
Contact
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Andres Metspalu (Population-based biobanks /Prof.)
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EGP, University of Tartu
Tartu 50410 Phone: +372 7 440243 Email: andres.metspalu@geenivaramu.ee |
Website
Funding agencies
The Estonian Genome Project Foundation was founded by the Government of the Republic of Estonia in 2001. The Estonian Genome Project of University of Tartu is a research institute reorganised from the Estonian Genome Project Foundation in April 1st 2007. The Estonian Genome Project of University of Tartu carries out the Estonian Genome Project (EGP) with the goal to create a database (biobank) of health, genealogy and genome data from 100 000 individuals by 2010.
The database will make it possible to carry out research both in Estonia and outside to find links between genes, environmental factors, lifestyles and common diseases (cancer, diabetes, depression, cardio-vascular diseases, etc).
The legal framework for the activities of the EGP consists of the Constitution of the Republic of Estonia, the Human Genes Research Act (HGRA), the Personal Data Protection Act, the Databases Act and the Council of Europe Convention on Human Rights and Biomedicine.
In 2001 the EGP started developing a quality management system and in 2003 received an ISO 9001:2000 certificate.
EGP has laboratory for DNA research, IT unit and data (health information and biological samples) collection unit. There are 40 employees in EGP at the moment.
The goal of the Estonian Genome Project is to create a database of health, genealogy and genetic data that would comprise a large part of the Estonian population – The Biobank. The database will make it possible to carry out research both in Estonia and outside to find links between genes, environmental effects and common diseases (cancer, diabetes, depression, cardio-vascular diseases, etc.) and to apply the information gained from research in making new discoveries in genomics and genetic epidemiology, which eventually lead to increasing the efficiency of health care.
Besides the Estonian medical system the database of the Estonian Genome Project will give an impetus also to the biopharmaceutical industry and will hopefully bring direct investments and resources to Estonia for the financing of scientific research projects.
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| Study design | Cohort, mixed design |
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| Type of participants | Individuals |
| Target or final number of participants | 50000 |
| Target or final number of DNA | 50000 |
Selection criteria
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Minimun: 18 years |
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Estonia |
Recruitment procedures
People will be asked by their family physicians or data collectors to become gene donors, they get information about the EGP and after deciding they have to sign the informed consent form, will go through computer assisted questionnaire and 50 ml blood sample will be taken afterwards.
Data Sources
| Cross-sectional | Repeated/continuous | |
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Collection procedures
The data collection process at the data collector's office consists of three steps:
• obtaining a Gene Donor Informed Consent
• taking a tissue sample
• filling the questionnaire of Health and Genealogical Data.
As the first step the doctor introduces person, who wishes to become a gene donor, EGP and its goals and the role of a gene donor in the project. If the person wishes to become a gene donor, he or she signs the Gene Donor Consent Form.
After that the data collector fills digital Questionnaire of Health and Genealogical Data by interviewing the gene donor. The questionnaire consists of 15 modules and contains in total 182 questions and filling order is Computer Aided Personalized Interview. Filling of the questionnaire takes approximately 1–1.5 hours. Health questions are according to ICD10 structure.
The filled-in questionnaires are sent to EGP via internet in the form of encrypted documents.
A tissue sample (50 ml of blood) is taken from a gene donor before or after filling of the questionnaire. Each tissue sample is marked with a special bar code. Samples are stored in the data collector’s office in a definite temperature range (6 ± 2 °C) until its delivery to a transportation company.
A courier service delivers tissue samples to EGP within 36 hours from the moment of taking the tissue sample, observing the security and other regulations established.
EGP accepts tissue samples according to the procedures of the ISO standard developed. All tissue samples which conform with requirements are accepted for processing in the EGP laboratory before 48 hours have passed from taking the tissue sample. During the processing the tissue sample is separated into different blood components (plasma, erythrocytes and leucocytes), and DNA is separated from leucocytes. Considering the large number of tissue samples processed, an environment-friendly technique has been developed for DNA separation.
The total amount of DNA separated from each tissue sample is measured, and the quality testing of the DNA separated is carried out with three different methods. The results obtained are stored in the EGP database in a digital form, which allows to supply each DNA sample issued from the gene bank with a document proving its quality. 3.5 ml of blood plasma, 1 ml of leucocytes in a special freezing compound and the total DNA which conforms with quality requirements are stored in the storage facility of the EGP. Special CBS™ Mapi straws are used for packaging and storage. Straws are stored in containers filled with liquid nitrogen, at ultra-low temperature (from -150 to -185 °C), the data are stored in the database under the storage addresses.
The data of gene donors are stored anonymously in the EGP database and they can be connected to the gene donor, i.e. decoded, only in cases stipulated in the Human Genes Research Act.
The data collection process of EGP is in accordance with the international standard GCP (Good Clinical Practice) and the ISO 9001:2000 certificate No. 199057A has been issued to it. According to the Human Genes Research Act, the Data Protection Inspectorate exercises supervision over data collection and data processing by EGP.
Follow up procedures
No information available
Baseline principal variables of interest
Health information
Physical / Biochemical measures
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Sociodemographic Characteristics
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Socioeconomic Characteristics
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Life habits / Behaviours
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Physical environment
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Sample management
Biological samples
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Biological samples format
| Fresh | Frozen | Dried (paper) | Other | Specification | |
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| Blood |
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Legend
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Allow access to data or samples to external researchers
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Current status
| Phase | Start | End |
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| Preparation phase/Pilot | 1999 | 2003 |
| Recruitment / initial data collection | 2003 | 2010 |
| Follow-up of participants | -- | -- |
| Current number of participants recruited | 42000 in date of 02/01/2010 |
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| Current number of collected DNA samples | 42000 in date of 02/01/2010 |
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| Document type | Availability | |
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| 1 | General study protocol | |
| 2 | Specific protocols/procedures (data collection, samples management, etc.) |
Andres.metspalu@geenivaramu.ee |
| 3 | Questionnaires |
Andres.metspalu@geenivaramu.ee |
| 4 | Physical and cognitive measures | |
| 5 | DNA processing | |
| 6 | IT | |
| 7 | Ethics | |
| 8 | Consent forms | |
| 9 | Pamphlet / project description | |
| 10 | Governance / ethics documentation | |
| 11 | Human Genome Research Act |
| Name | Estonian Genome Project Questionnaire |
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| Last update | 03/17/2009 |
| Version or reference year | EGP-Q-1.00; EGP-Q-2.00; EGP-Q-3.00 |
Questionnaire owner
Contact
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Andres Metspalu (Population-based biobanks /Prof.)
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Estonian Genome Project EGP
Tartu 50410 Phone: +372 7 440243 Email: andres.metspalu@geenivaramu.ee |
Information on validity
Validation of the questionnaire has not been carried out yet
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Respondent
Administration environment
Administration mode
Administration format
Administration language
Available Format
NOTICE: HTML document format may differ slightly from the actual questionnaire. Please refer to the original PDF document for exact reproduction.
| Name | Estonian Genome Project Questionnaire |
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| Number of Question Blocks | 46 |
| Name | Physical and cognitive measures |
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| Last update | 03/18/2009 |
| Collected at phase | Data collecting, III version of EGP questionnaire |
| Year interval | 2007 to 2010 |
Contact
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Andres Metspalu (Population-based biobanks /Prof.)
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Tartu 50410
Phone: +372 7 440243 Email: andres.metspalu@geenivaramu.ee |
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Legend
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Bone density (values of T-sector from medical records of gene donors, if available)
Vision and related functions (both eyes dioptries and visuses from medical records of gene donors, if available or the values given by the gene donor)
FUNCTIONS OF THE CARDIOVASCULAR AND RESPIRATORY SYSTEMS
Functions of the cardiovascular system
Heart rate (in 15 seconds has to be measured)
Functions of the respiratory system
Respiratory functions (values of FVC and FEV1 and spirography performing date from medical records of gene donors, if available)
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Administration environment
Hospital, clinic, university or recruitment center
Staff administering test
Professionals (nurses, clinicians, etc)
Interviewers/research assistants
Other
| Administration language | Estonian |
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Standard operating procedures (SOPs) or reference information
| Name | DNA Processing |
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| Study name | Estonian Genome Center of University of Tartu [EGC] |
| Last update | 02/27/2009 |
Contact
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Merli Hass
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EGP
Email: merli.hass@geenivaramu.ee |
| Utilization conditions | None |
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Legend
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| Sample name | Blood | |
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| Main laboratory | Laboratory Estonian Genome Project University of Tartu | |
| Sample labels/traceability (% of samples) |
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| Pre-extraction sample storage format | Substrate storage condition |
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| Protocols | ||
| DNA extraction | DNA extraction method |
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| Protocols | ||
| DNA handling and storage | DNA diluent |
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| DNA quantification | Methods |
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| Protocols | ||
| DNA quality control | Percentage of samples that are tested | |
| DNA quality method |
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| Protocols | ||
| Name | Information Technologies |
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| Study name | Estonian Genome Center of University of Tartu [EGC] |
| Last update | 10/28/2009 |
Contact
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Erkki Leego
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Estonian Genome Project, University of Tartu
Tartu 50410 Phone: +372 5332 9211 Email: erkki.leego@geenivaramu.ee |
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Legend
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| Biobanking areas covered | QureServer3.5.2 | MAPI | LIMS 4.1 | Kodeerimiskeskus | GenoByte | DataCollector 2.6.1.433 |
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| Participant recruitment (ex: CATI, CRM) |
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| Data collection | ||||||
| Sample collection, storage and processing |
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| Data repository |
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| Other |
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| Programming language | QureServer3.5.2 | MAPI | LIMS 4.1 | Kodeerimiskeskus | GenoByte | DataCollector 2.6.1.433 |
| Name and version of programming language | Java 1.6 | Java 1.6 | Java | Java | ||
| Internal/external development | QureServer3.5.2 | MAPI | LIMS 4.1 | Kodeerimiskeskus | GenoByte | DataCollector 2.6.1.433 |
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| By an external company |
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| Shareability | QureServer3.5.2 | MAPI | LIMS 4.1 | Kodeerimiskeskus | GenoByte | DataCollector 2.6.1.433 |
| Freely available |
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| Purchaseable |
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| Needs extensive work |
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| Not for share | ||||||
Biobanking areas covered
Name and version of programming language
Java 1.6
Internal/external development
Shareability
Biobanking areas covered
Internal/external development
Shareability
Biobanking areas covered
Name and version of programming language
Java 1.6
Internal/external development
Shareability
Biobanking areas covered
Name and version of programming language
Java
Internal/external development
Shareability
Biobanking areas covered
Internal/external development
Shareability
Biobanking areas covered
Name and version of programming language
Java
Internal/external development
Shareability
No information available