Session 3A: The Measure of Success Metrics Used to Describe the Utilisation of Biobanked Samples

Transcription

1 Session 3A: The Measure of Success Metrics Used to Describe the Utilisation of Biobanked Samples Current Condition and Issues of Clinical Biobanks in Japan: A Point of View from Laboratory Medicine Department of Laboratory Medicine & Division of Clinical Genetics and Proteomics, Chiba University Hospital, JAPAN Kazuyuki Matsushita

2 Today s Contents 1. Introduction of biobank networks in Japan. 2. Clinical biobanks and sample standardization for biomarkers and clinical sequence for cancers. 3. Development of human resources and professional staffs for clinical biobanks and clinical sequence.

3 Purposes of biobanks Backgrounds: Purposes of biobanks has been changing. Samples and their standardization are different depend on the purposes. Before 2000 Biomarkers (Serum, plasma) Present Cohort, rare disease study (human genome DNA) Clinical sequences for cancer therapy and diagnosis (somatic/germline DNA) Clinical examination

4 Samples Two types of biobanks need standardization Clinical Data National biobanks UK NIH(US) AMED(JPN) 6NC(JPN) Biobanks belong to hospitals Information for TR DNA peptides DNA Biomarkers (Serum, plasma) Cohort study (human genome) Clinical sequences for cancers (somatic/germline DNA)

5 ,JPN

6 Clinical sequences of University biobanks for cancer treatment Clinical biobanks in University hospitals Basic research Collaboration research with Multi-institutes Original articles New findings Research institutes National Mega Banks Tissue samples High quality samples with international standardization (ISO15189/TC276, TC212) New drags with Pharma company Biomarkers, cohort study, rare disease, Clinical sequences for cancer treatment Samples with clinical data Cancer research Clinical sequence Feedback to cancer patients

7 Clinical biobank and sequencing for precision medicine in cancers Shinshu Univ. Kyoto Univ. Okayama Univ. Chiba Univ. Saga Univ.

8 Clinical Biobank Network, JPN Chiba University Hunman samples Electric health record anonymization+ automatic extraction Clinical biobank Human samples Government Institutes Public Institutes Clinical data

9 Factors that affect the quality of biobank samples Factor 1 Factor 2 Factor 3 Factor 4 Factor 5 患者 collection centrifuge store measure 1. Circadian variation 2. Foods 3. Alcohol 4. Cigarettes 5. Gender 6. Age 7. Exercise 8. Position 9. Pregnancy 10. Drugs A. Collection tube B. Needle C. Avascularization D. clenching E. location F. serum/plasma G. Procoagulant H. anticoagulant 1) Collection tube 2) centrifugation 3) temperature 4) time 5) dlivery a. period b. temperature c. tube d. Freeze thaw e. times I. item II. methods III. principle IV instrument V. reagent VI. Standard substance VII. techniques

10 Automatic pipetting devise and deep freezer at -150 Automatic pipetting devise Deep freezer at -150

11 Principles of MALDI-TOF MS 1. MALDI: Matrix-assisted laser desorption/ionization H + H + H+ Nitrogen laser 2. TOF MS: Time-of-flight mass spectrometer Lasar ion beam (337nm) Sample molecules Matrix molecules Target Linear detecot Sample

12 Mass spectrometry for QC of sera/plasma samples intensity Serum Autoflex II TOF/TOF MS WCX beads Binding Washing Elution Matrix (CHCA) Anchorchip Target ClinProtRobot SDS-PAGE Mass spectrum analysis

13 Nnumber of the peaks Pre-analysis revealed the change of peptides in biobanks 100 [%] Type B 4955 Da Type C 5890 Da [hrs] Type A 1465 Da type C type B type A WCX IMAC-Cu C8 Umemura H et al. Clin. Chim. Acta 406 (2009)

14 Human Samples in Our Biobanks Tissues (DNA, RNA) Clinical sequences Blood (DNA, RNA) cohort, biomarkers Sera biomarkers Plasma biomarkers Cerebrospinal fluids biomarkers Urine biomarkers QC depends on kinds of samples.

15 Flowchart of Clinical Sequences and Expert Panel for cancer therapy 2 days 2 days 1 day 3 days sample DNA extraction Library NGS Analysis Expert panel QC of FFPE DNA Integrity Number CNV, translocation, oversight Data base (somatic, germ line) Pathologist Laboratory (ISO15189, CLIA,CAP)

16 Quality control for genetic testing(iso17511)

17 Standardized Reference Materials for Biobanks and Clinical Sequences Human samples Blood Tissues others Pre-analytical processes Reference materials for quality control Hybridization to microarray Laser excitation Procedures for DNA analysis Laser emission Analysis process Reference materials for proof + = Data analysis and precise DNA quantification 8x 4x 2 2x 4x 8 Post-analytical processes

18 Inquiry National Institute of Advanced Industrial Science and Technology National Metrology Institute of Japan (NMIJ) Tsukuba, Umezono 1-1-1, Ibaraki, Japan Handling companies General Science Corporation, Japan GL Sciences Inc., Japan KANTO CHEMICAL CO., INC., Japan SEISHINTRADING CO., LTD.,Japan Wako Pure Chemical Industries, Ltd. Japan

19 Biobanks and professional staffs required for clinical sequence to cancer therapies Patient Doctor Easy-to-understand report Pre-analysis Selection of cancer drugs Pathologists Clinical technicians Clinical biobank of cancer tissues Integrated database of clinical sequences Costum panel) Laboratory center (ISO15189, CLIA,CAP) Genetic counselling Genetic counsellers Hereditary cancers Cancer board Doctors, pathologists, Clinical laboratory physician, Nurses, pharmacologists CRC, Clinical trials in the Hospitals pharmacologists Interpretation Expart panel Doctors, pathologists, Clinical laboratory physician, Nurses, pharmacologists Patients backgraound

20 Summary/Conclusion Biobank samples are used for many purposes, including novel biomarkers detection, cohort study and clinical sequences for cancer therapies. Sample types and their quality management are different depend of the purposes. International reference materials should be established. We have established the clinical biobank networks in Japan that are pivotal for recent cancer clinical sequences. Clinical sequences with biobanks and clinical data bases are necessary for precision medicine for cancers in the future. Finally, cultivation of human resources are required for clinical sequences for cancer treatment.

21 Acknowledgements Chiba University, JPN Kyoto, Kiyomizu-Dera Mt. Fuji Kyoto University, JPN Okayama University, JPN Hokkaido University, JPN Shinshu University, JPN Saga University, JPN Thank you.