Le banche dei tessuti

Transcription

1 Le banche dei tessuti Rete Oncologica del Piemonte e della Valle d Aosta: Le ricerche e realizzazioni negli anni Maggio 2010 GIORGIO INGHIRAMI Department of Biomedical Science and Human Oncology Center of Experimental Medicine and Research (CeRMS) University of Turin

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4 Molecular Medicine: Personalized Approaches

5 Molecular Medicine as a Complex Continuum Molecular Medicine Clinical Research Imaging Molecular Biology Pathology

6 The People Trial Managers Clinicians Radiologists MRI Technicians Geneticists Molecular Biologists Geneticists Lab Technicians Molecular Biologists Pathologists

7 The Activities Study Creation Clinical Data Correlation Patient Enrollment SNP Identification Clinical Data Collection Expression Analysis Image Sharing & Analysis Tissue Banking Molecular Profiling Expression Analysis: Conduct a gene expression analysis from the patient samples. Cluster and map the resulting pathways to identify the genes. SNP Identification: List of genes identified from the pathways are used to query database for a list of SNPs from those genes. Clinical Data Correlation: Correlate the known SNP cooccurrence with cancer subtypes by plotting the occurrence frequency of SNPs within targeted pathways.

8 Biobanking, a heterogeneous concept

9 Developing a Tissue Repository MODELS OF TISSUE RESOURCES Tissue Banking Prospective Collection Combination of Prospective and Banking Virtual Repository

10 The Isolated Tissue Bank Manual Re-entry of clinical information into non-standard data elements in stand-alone databases and spread-sheets Variable IT architecture and support Existence depends of research grants and powerful Principle Investigators Local IRB, Consent and Permission Procedures, HIPAA and security issues, TUC, etc. Limited access from the general research community Extreme inefficiencies and costs

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12 Attivita della Banca 297 vials 358 vials

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14 catissue, SPIN and TIES The catissue accepted SPIN/TIES as our first major initiative because it represents these concepts on a grand scale TIES takes two major (and despised) components of every medical center s

15 Esperienze in campo internazionale

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17 Center of Research and Medical Science Tissue network Fugeco

18 ALCL share a common gene signature distinct from PTCL/U and AILT Piva et al JCO 2009

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20 Annotation is vital Long term follow up Follow up Treatment outcome Stage / Grade Molecular stratification Diagnosis

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22 Developing a Tissue Repository What issues should be considered in operating a Human Tissue Repository?

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25 Ethics The interests of the patient must come first, but equally it is unethical not to use material surplus to diagnostic requirements to benefit other patients in the future Informed consent should be obtained whenever practical - certainly for prospective collections. Level of consent offered to the donor should reflect the degree of risk to the patient

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27 What do the patients think? Review of the Peterborough NHS tissue bank Time period: to interviews, 38 refusals No single reason - varied from cultural/language difficulties (most common - 4 cases) to wishing to keep their tissue. Despite the fact that the patients were informed would be used by pharmaceutical industry (i.e. commercial use) only 2 patients were against commercial involvement Jack AL, Womack C (2003) BMJ 327: 262

28 Issues to consider Resources Space (Laboratory and Administrative) Personnel Hours of operation Services to be performed Qualification of personnel/cross-training Equipment Supplies Support by Pathology and Surgery

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30 It s all about the sample Science Requires Quality Otherwise Garbage In Garbage Out

31 Clinical Bio-specimens Lifecycle Medical Treatment Clinical Biobanking Medical Research Donor Consent Medical/ Surgical Procedures Pre-acquisition Measure in Minutes Transport Receiving Storage Processing Release, Scientific Annotation Quality Distribution Analysis Transport Acquisition Post Acquisition Measure in Years Pre- Release Restocking/ Destruction Antibiotics Other drugs Type of anesthesia Anesthesia duration Arterial clamp time Processing Time Temperature Fixation Agent SOP s Storage Media Storage Method Storage Temperature Quality Controls Pathology Review Disease Site Clinical Data Data Standards SOP s Study Design SOP s Equipment Cohort Definition SOP s Material Transfer Ethics Courtesy Peter Riegman Erasmus University and Marble Arch International Working Group on Human Specimen Biobanking for Biomedical Research

32 SAFETY IN TISSUE RESOURCES ALL TISSUES ARE POTENTIALLY DANGEROUS SLIGHT LOSS OF ABILITY TO INFECT LARGE LOSS OF ABILITY TO INFECT FRESH FROZEN FIXED ADDITIONAL LOSS OF ABILITY TO INFECT FIXED AND PROCESSED TO PARAFFIN

33 Guidelines and best practices for organization of the biobank core processes

34 Developing a Tissue Repository What services will your repository provide?

35 Role of Tissue Banking in Cancer Research Clinical Database Tissue Bank Clinical Trials High Throughput Expression microarrays Mass Spectroscopy Tissue Microarray Validation of targets Candidate biomarkers Clinical Trials using Biomarkers to direct therapy

36 Developing a Tissue Repository Quality Control Need for Quality Control (QC) How will you perform QC? - Histology or molecular analysis Extent of Information Provided - e.g. % viable tumor cells Resources required

37 Importance of QA Good quality research depends on good quality material Material must be what it says it is on the pot i.e. needs to be pathologically reviewed Must be fit for purpose needs to be handled correctly and stored correctly Should be agreed SOPs that are adhered to

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39 How can we better analyse research data from tissue banks? Develop Bioinformatics to enable us to combine data from research studies with clinical information Use computer models to define biomarker profiles that enable us to better diagnose different subtypes of cancer and to decide which patient should be given which therapy (and in which order)

40 NCI biomedical informatics Goal: A virtual web of interconnected data, individuals, and organizations redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise

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42 Where are we going with biobanking?