Medicon Valley Cluster Visit joyce carlson regional biobank centre


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Medicon Valley Cluster Visit joyce carlson regional biobank centre

  1. 1. Region Skånes BiobankDirector Eva Arveström LarssonCo-ordinator Marie.B.SverudMedical Advisor Joyce Carlson
  2. 2. University hospitalLocal hospitalAcute 24/7 hospitalPrimary care1 200 000 inhabitantsin SkåneSouthern Swedish Healthcare Region
  3. 3. 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
  4. 4. Biobank ResearchHealthcare collectionsHealth CareRegistriesLegal / EthicalServicePopulation basedStudyClinical cohortsCo-ordinationTechnology PlatformsBiobankRegistriesClinical / Epidemiologic / BiochemicalToxicological / Basic Research
  5. 5. Our Biobank contains > 8 millionsamples• Numerous collections of biological samples• Derived from identifiable (via codes) humans• Who have given informed consent for thesamples 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
  6. 6. About half were obtained within routinehealthcare• Pathology and cytology– Autopsy sections (from 1878 onward)– Biopsy and surgical specimens,– FFPE and Fresh frozen tissue– TissueMicroArrays• Used to identify cellular biomarkers, drugtargets, HUPO project.• Fresh frozen tumor tissue is used for wholegenom sequencingCytology – smears and liquidbased cytology
  7. 7. About half were obtained within routinehealthcareMicrobiology, > 2.2 million samples:– Maternity cohort, serum samples from all pregnantwomen during week 14– Blood donor screening– Serological diagnostic testing (suspicion ov viralinfections)• Valuable to identify new pathogens• Valuable in search for prediagnostic biomarkers• Possible to study environmental/toxic exposuresOther collections in AMM, KIT, Clin.Genetics
  8. 8. Population based epidemiologicalstudies - 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, Lungcancer will start 2013 - 2014
  9. 9. Population based epidemiologicalstudies• Many samples, comprehensivequestionnaire• Long maturation time (since 1991 900cases of breast cancer)• Easy to obtain samples/info from matchedcontrols• Excellent source to identify risk factors• Can link lifestyle and biomarkers
  10. 10. 010002000300040005000600070008000196919711973197519771979198119831985198719891991199319951997199920012003NumberofcancercasesSweden (Umeå)Sweden (Malmö)NorwayIcelandFinlandAnnual numbers of registered cancer casesamong subjects in the Nordic biobanksdiagnosed after serum donation, by region.CCPRB6
  11. 11. Number of male cancer cases amongblood donors in the Nordic biobanks0100020003000400050006000700080009000 0-45-910-1415-1920-2425-2930-3435-3940-4445-4950-5455-5960-6465-6970-7475-7980-8485+AgeNumberofcancercasesOtherVirus testingPopulation HealthCCPRB6
  12. 12. Number of female cancer cases amongblood donors in the Nordic biobanks01000200030004000500060000-45-910-1415-1920-2425-2930-3435-3940-4445-4950-5455-5960-6465-6970-7475-7980-8485+AgeNumberofcancercasesOtherVirus testingPopulation HealthMammary cohortMaternity cohortsCCPRB6
  13. 13. Ongoing Clinical Cohort Studies• Breast Cancer – 3 500 donors since 2010• Colorectal cancer, lymphoma, Lung cancer and prostatecancer• LHG – Lund Heart Gene all patients admitted to CardiacIntensive Care• LCPR – Lund Cardiopulmonary Register• STROKE• ANDIS – all new diabetics in Skåne• DIACT – Diabetes Activity Study• PARLU – Parkinson’s Disease in Lund
  14. 14. 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
  15. 15. 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 qualityassured Biobank (is rarely done)
  16. 16. Sharing responsibilityPI (PSA)• Planning• Ethical approval• Informed consent• Economicresponsibility• Management ofinformation• Has access tosamplesClinicalChemistry• Planning• Sampling• Sample handling• Registration• Freezing• Preanalytical QA• TrackingBiobank• Planning• Transport• Storage• Derivitisation• Retrieval• Distribution• Quality assurance• Tracking
  17. 17. Ethical, legal and social issues• Participant safety, autonomy and privacy• Unique identifiers / code keys / anonymity• Specific / general ”informed consent”• Reporting of research results
  18. 18. Sample collectionStudyBiobankClinicalinformationData fromquestionnairesSamplesProjects (research)Analytical resultsPersonaldataXEthical approval
  19. 19. Informed consent• Specific or general purpose– For medical research– For research concerning the cause andtreatment of amyotrophic lateral sclerosis• Who will have access to my sample andinformation?• Can I back out if I have regrets? How?• Will I be informed of results?
  20. 20. 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
  21. 21. 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
  22. 22. 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
  23. 23. Sample Quality: Preanalyticalfactors• 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
  24. 24. Goals• To improve the quality, efficiency,accessibility and use of existing biobanksfor research• To aid in the development of new topquality biobanks• To protect the integrity of individualsample donors through active ethicalguidelines
  25. 25. Research strategy• Is my favorite disease inherited?– Twin register,– Multigeneration registerSearch for cases and/or controls– Cancer register,– Diagnosis register
  26. 26. Research strategy• Identify biological samples fromcases/controls– Biobank registries• Retrieve coded samples / information– Perform biochemical / genetic testsusingavailable technical platforms
  27. 27. Biobank Usefulness over time• Updates of ” associated information”• Increase in disease endpoints• New technology can increase informationcontent• Depletion of significant samples ?
  28. 28. Can we co-operate in biobank research ?• Yes – Swedish Ethical Approval necessary• Biobank can deliver samples – but noassociated information• Best to establish collaboration with PI(Responsible for Sample Collection, PSA)• Attempts to establish catalogues areongoing