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

1000

2000

3000

4000

5000

6000

7000

800019

69

1971

1973

1975

1977

1979

1981

1983

1985

1987

1989

1991

1993

1995

1997

1999

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