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Region Skånes Biobank
Director Eva Arveström Larsson
Co-ordinator Marie.B.Sverud
Medical Advisor Joyce Carlson
University hospital
Local hospitalAcute 24/7 hospital
Primary care
1 200 000 inhabitantsin Skåne
Southern Swedish Healthcare Region
The Scandinavian Goldmine Unique personal identifiers (personnummer)
Regional Cancer Registries
Swedish Family – Cancer Registry
Diagnoses in Hospital Care Registry
Twin Registry
Multiple generation registry Regional Biobank registries
Pharmacy registries
Diagnoses in outpatient care
Biobank Research
Healthcare collectionsHealth Care
RegistriesLegal / Ethical
Service
Population based Study
Clinical cohorts
Co-ordination
Technology Platforms
Biobank Registries
Clinical / Epidemiologic / BiochemicalToxicological / Basic Research
Our Biobank contains > 8 million samples
• Numerous collections of biological samples
• Derived from identifiable (via codes) humans
• Who have given informed consent for the samples to be saved and used– for the donor’s own healthcare,
– for quality assurance, development and for teaching
– For research in a restricted or broad sense
About half were obtained within routine healthcare• Pathology and cytology
– Autopsy sections (from 1878 onward)– Biopsy and surgical specimens, – FFPE and Fresh frozen tissue– TissueMicroArrays
• Used to identify cellular biomarkers, drug targets, HUPO project.
• Fresh frozen tumor tissue is used for whole genom sequencing
Cytology – smears and liquidbased cytology
About half were obtained within routine healthcareMicrobiology, > 2.2 million samples:
– Maternity cohort, serum samples from all pregnant women during week 14
– Blood donor screening– Serological diagnostic testing (suspicion ov viral
infections)• Valuable to identify new pathogens• Valuable in search for prediagnostic biomarkers• Possible to study environmental/toxic exposuresOther collections in AMM, KIT, Clin.Genetics
Population based epidemiological studies - examples• Malmö Preventive project 1974 – present
• Malmö Diet and Cancer Study 1991-1996 –present ca 30 000 participants each
• EpiHealth start 2011, GÅS since 2000
• SCAPIS will start in Skåne 2013 after pilot
• Big3 Cardiovascular disease, COLD, Lung cancer will start 2013 - 2014
Population based epidemiological studies• Many samples, comprehensive
questionnaire• Long maturation time (since 1991 900
cases of breast cancer)• Easy to obtain samples/info from matched
controls• Excellent source to identify risk factors• Can link lifestyle and biomarkers
0
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7000
800019
69
1971
1973
1975
1977
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1987
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1995
1997
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2001
2003
Num
ber o
f can
cer c
ases
Sweden (Umeå)
Sweden (Malmö)
Norway
Iceland
Finland
Annual numbers of registered cancer cases among subjects in the Nordic biobanks
diagnosed after serum donation, by region.
CCPRB6
Number of male cancer cases among blood donors in the Nordic biobanks
0
1000
2000
3000
4000
5000
6000
7000
8000
90000-
4
5-9
10-1
4
15-1
9
20-2
4
25-2
9
30-3
4
35-3
9
40-4
4
45-4
9
50-5
4
55-5
9
60-6
4
65-6
9
70-7
4
75-7
9
80-8
4
85+
Age
Num
ber o
f can
cer c
ases Other
Virus testing
Population Health
CCPRB6
Number of female cancer cases among blood donors in the Nordic biobanks
0
1000
2000
3000
4000
5000
60000-
4
5-9
10-1
4
15-1
9
20-2
4
25-2
9
30-3
4
35-3
9
40-4
4
45-4
9
50-5
4
55-5
9
60-6
4
65-6
9
70-7
4
75-7
9
80-8
4
85+
Age
Num
ber o
f can
cer c
ases
Other
Virus testing
Population Health
Mammary cohort
Maternity cohorts
CCPRB6
Ongoing Clinical Cohort Studies• Breast Cancer – 3 500 donors since 2010• Colorectal cancer, lymphoma, Lung cancer and prostate
cancer• LHG – Lund Heart Gene all patients admitted to Cardiac
Intensive Care• LCPR – Lund Cardiopulmonary Register• STROKE• ANDIS – all new diabetics in Skåne• DIACT – Diabetes Activity Study• PARLU – Parkinson’s Disease in Lund
Strengths of Clinical Cohorts
• Linkage to national clinical quality registers– To follow course, treatment and prognosis
– To identify new biomarkers
– To hopefully improve basic healthcare and
– Possibly provide personalized medicine
– For the sample donors themselves
• Rapid recruitment, > 98 % consent,
• e.g. 3 500 cases of breast cancer since 2011
Clinical Trials: Drugs / Devices
• Require ethical approval• Are registered as Sample collections• Have access to preanalytical handling• Have transport service• Samples may be stored within quality
assured Biobank (is rarely done)
Sharing responsibility
PI (PSA)
• Planning• Ethical approval• Informed consent• Economic
responsibility• Management of
information• Has access to
samples
Clinical Chemistry
• Planning• Sampling• Sample handling• Registration• Freezing• Preanalytical QA
• Tracking
Biobank
• Planning• Transport• Storage• Derivitisation• Retrieval• Distribution• Quality assurance
• Tracking
Ethical, legal and social issues
• Participant safety, autonomy and privacy
• Unique identifiers / code keys / anonymity
• Specific / general ”informed consent”
• Reporting of research results
Sample collectionStudy
Biobank
Clinical information
Data fromquestionnaires
Samples
Projects (research)
Analytical results
Personal data
X
Ethical approval
Informed consent
• Specific or general purpose– For medical research– For research concerning the cause and
treatment of amyotrophic lateral sclerosis• Who will have access to my sample and
information?• Can I back out if I have regrets? How?• Will I be informed of results?
Types of samples
• Fresh frozen tissue (normal and cancer)• FFPE tissue• Cervical brush cytology – Pap smears, BAL• Whole blood, buffy coats, buccal swabs• Dried blood spots (Guthrie blots)• Lymphocyte preps• Serum/plasma, urine, etc.• Hair, nails, bone, joint fluid
Ongoing developments RS Biobank
• Infrastructure– Pipetting robots– Automated -80oC freezer– -150oC freezer– Biobanks LIMS (same as Labmed LIMS)– DNA extraction robot
• Co-ordination with Labmedicine– Preanalytical sample handling
National harmonisation GSB• Preanalytical sample handling
– Defined levels of service– Liquid-based samples– Tissue (pathology)– Quality assurance guidelines
• Minimal data set– For registration in Swedish Biobank Register– Sample collection, donor, sample, portion,
derivative
Sample Quality: Preanalytical factors
• Factors concerning donors– Diet, fasting, environmental exposures
• Blood sampling – technique, tubes• Sample treatment – centrifugation• Sample tracking• Effects of storage – type of tube etc.
– Number of aliquots, size of sample
Goals
• To improve the quality, efficiency, accessibility and use of existing biobanks for research
• To aid in the development of new top quality biobanks
• To protect the integrity of individual sample donors through active ethical guidelines
Research strategy
• Is my favorite disease inherited? – Twin register,
– Multigeneration register
Search for cases and/or controls– Cancer register,
– Diagnosis register
Research strategy
• Identify biological samples from
cases/controls– Biobank registries
• Retrieve coded samples / information– Perform biochemical / genetic tests
usingavailable technical platforms
Biobank Usefulness over time
• Updates of ” associated information”• Increase in disease endpoints• New technology can increase information
content• Depletion of significant samples ?
Can we co-operate in biobank research ?
• Yes – Swedish Ethical Approval necessary• Biobank can deliver samples – but no
associated information• Best to establish collaboration with PI
(Responsible for Sample Collection, PSA)• Attempts to establish catalogues are
ongoing