medicon valley cluster visit joyce carlson regional biobank centre
TRANSCRIPT
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Region Skånes Biobank
Director Eva Arveström Larsson
Co-ordinator Marie.B.Sverud
Medical Advisor Joyce Carlson
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University hospital
Local hospitalAcute 24/7 hospital
Primary care
1 200 000 inhabitantsin Skåne
Southern Swedish Healthcare Region
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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
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Biobank Research
Healthcare collectionsHealth Care
RegistriesLegal / Ethical
Service
Population based Study
Clinical cohorts
Co-ordination
Technology Platforms
Biobank Registries
Clinical / Epidemiologic / BiochemicalToxicological / Basic Research
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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
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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
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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
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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
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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
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800019
69
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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
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Number of male cancer cases among blood donors in the Nordic biobanks
0
1000
2000
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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
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Number of female cancer cases among blood donors in the Nordic biobanks
0
1000
2000
3000
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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
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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
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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
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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)
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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
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Ethical, legal and social issues
• Participant safety, autonomy and privacy
• Unique identifiers / code keys / anonymity
• Specific / general ”informed consent”
• Reporting of research results
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Sample collectionStudy
Biobank
Clinical information
Data fromquestionnaires
Samples
Projects (research)
Analytical results
Personal data
X
Ethical approval
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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?
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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
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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
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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
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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
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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
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Research strategy
• Is my favorite disease inherited? – Twin register,
– Multigeneration register
Search for cases and/or controls– Cancer register,
– Diagnosis register
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Research strategy
• Identify biological samples from
cases/controls– Biobank registries
• Retrieve coded samples / information– Perform biochemical / genetic tests
usingavailable technical platforms
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Biobank Usefulness over time
• Updates of ” associated information”• Increase in disease endpoints• New technology can increase information
content• Depletion of significant samples ?
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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