The contribution of the population biobank of ISPO

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1 The contribution of the population biobank of ISPO Domenico Palli Molecular and Nutritional Epidemiology Unit - ISPO, Florence d.palli@ispo.toscana.it 9 March 2012, Rome Challenges and Opportunities of the Italian Hub of Population Biobanks (HIBP)

2 Population bio-banks at ISPO blood samples from 945 population controls in the frame of the Italian Multicenter Case-control Study on Diet and Gastric Cancer funded by NCI USA To evaluate the relationship between plasma levels of antioxidant vitamins and cholesterol, and sociodemographic characteristics, life-style factors, and dietary intake of selected nutrients in a sample of the Italian population. To estimate the prevalence of chronic atrophic gastritis, H.pylori antibodies and their dietary and demographic determinants blood samples from a random sample of subjects residing in Florence To evaluate the correlation between the H.pylori seroprevalence and gastric cancer rates (EURGAST, Lancet 1993)

3 Population Biobanks at ISPO EPIC STUDY European Prospective Investigation into Cancer and Nutrition - Co-ordinated by dr Elio Riboli currently at Imperial College, Department of Epidemiology & Public Health, London centres in 10 European Countries - Started in 1993 in progress.

4 EPIC collaborating centres ad subjects enrolled Subjects Questionnaires Q + Blood France Italy Spain UK The Netherlands Greece Germany Sweden Denmark Norway Total TROMSØ UMEÅ AARHUS MALMÖ COPENHAGEN CAMBRIDGE UTRECHT OXFORD BILTHOVEN POTSDAM PARIS HEIDELBERG IARC MILAN LYON OVIEDO TURIN SAN SEBASTIAN FLORENCE PAMPLONA BARCELONA NAPLES MURCIA GRANADA RAGUSA ATHENS

5 EPIC-Italy cohort Men Women ALL Turin 6,047 4,557 10,604 Varese 2,557 9,526 12,083 Florence 3,514 10,083 13,597 Naples - 5,062 5,062 Ragusa 3,053 3,350 6,403 Turin Varese Florence Total 15,171 32,578 47,749 Naples General population Healthy subjects Aged ys Residing in Florence District Enrolled in the period Ragusa

6 EPIC has unique features: Very large populations Detailed individual data collected by standardised questionnaires (diet, smoking, alcohol, occupation, physical activity, reproductive history, previous diseases ) Anthropometric measurements Bank of biological samples Follow-up through cancer registries, hospital discharges, etc. Possibility of investigating a wide range of hypotheses on cancer risk and prevention Availability of blood samples and individual epidemiological data

7 EPIC-FLORENCE: DIET QUESTIONNAIRE

8 PIC-FLORENCE: LIFESTYLE QUESTIONNAIRE

9 BASELINE Subjects enrolment Dietary and Lifestyle Questionnaires Anthropometric meaurements Blood samples ETIOLOGICAL STUDIES FOLLOW-UP Cancer diagnosis Vital status Death causes Lifestyle changes Development of databases on dietary and lifestyle data. Laboratory procedures for management and storage of blood samples DNA extraction - DNA analysis

10 EPIC Blood Collection and Storage 30 ml blood: 20 ml citrated + 10 ml dry 6 ml plasma, 2 ml buffy-coat, 2 ml red cells 4 ml serum Preparation of 24 aliquots of 450 µl for subject plasma 12 (red straws) serum 8 (yellow straws) buffy coat 4 (blue straws) red blood cells 4 (green straws) Total: 24 x subjects 9.16 Million aliquots

11 EPIC BIOREPOSITORY: PLASTIC STRAWS USED FOR STORAGE OF PLASMA, SERUM, RBC AND BUFFY COAT

12 EPIC BIOREPOSITORY SPECIFIC SOFTWARE FOR SAMPLES STORAGE MANAGEMENT SAMPLES MAPPING EASY IDENTIFICATION POSITION / RETRIEVAL OF SAMPLES 14 STRAWS (1 SAMPLE) 1 VISOTUBE (DIFFERENT COLOUR) 12 VISOTUBES (12 SAMPLES) 1 GOBLET 5 GOBELETS (60 SAMPLES) 1 CANISTER CANISTERS ( SAMPLES) 1 CRIOGENIC TANK CONCENTRIC ORDER - 6 CIRCLES (A-F) WITH DIFFERENT SIZE (A:34, B:28, C:22, D:17, E:11, F:6) MAPPING BY UNIQUE IDENTIFIER (NUMBER)

13 EPIC BIOREPOSITORY at IARC-WHO

14 EPIC BIOREPOSITORY at ISPO in FLORENCE

15 EPIC BIOREPOSITORY in FLORENCE STORAGE AND MANAGEMENT OF BIOLOGICAL SAMPLES ACCORDING TO SPECIFIC GUIDELINES

16 1. Technical and Operational Guidelines a. Biospecimen collection, processing, storage, retrieval and dissemination b. Collecting and Managing Clinical data c. Quality Assurance and Quality Control d. Biosafety e. Biorepository Informatics: data management

17 EPIC BIOREPOSITORY in FLORENCE BIOSAFETY: UNIVERSAL PRECAUTIONS PRACTICES

18 EPIC BIOREPOSITORY in FLORENCE BIOSAFETY: REGULATIONS AND PROCEDURES

19 2. Ethical, Legal and Policy Guidelines 1- Approval by IARC and Local Ethical Committee EPIC and several sub-projects in progress 2- Informed Consent signed at enrolment by each participant 3- Responsibility for custodianship of collected biospecimens and associated data ( local PI, IARC & Steering Committee) 4- Collaborations (Material Transfer Agreement)

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23 Preliminary results for HCB, DDT, DDE, BDE and 6 congeners of PCB (mean plasma values in pg/ml) Preliminary results for 116 EPIC-Florence participants (27 BC case-control pairs + 31 NHL case-control pairs) HCB DDT DDE PCB 118 PCB 138 PCB 153 PCB 156 PCB 180 PCB 170 BDE 47 N. MEAN MIN MAX SD For DDT e BDE-47 most values resulted under the level of quantification for the test; Also results for Cadmium and Lead are available. GPS analyses in collaboration with ISS and ICL.

24 The Population Bio bank at ISPO stores the sample collections of several molecular epidemiology studies: -Population samples from areas at high risk for specific cancer sites (stomach) -Samples from population-based series of cancer from-high risk families ( gastric cancer, breast & ovary cancer, male breast cancer) - Samples collected in randomised intervention trials aimed to modify dietary and life-style habits (- polyphenol-rich extravirgin olive oilve oil; - the DAMA trial: diet & physical activity in women at increased risk of BC because of high MBD)

25 The Population Bio-bank has also a Cancer Tissue Repository with matched blood samples and extensive individual information (diet & life-style, occupational history) for specific cancer sites: - Breast 90 pts - Colon & Rectum 120 pts - Stomach 150 pts (in collaboration with ISS) Cancer tissue specimens are snap-frozen in liquid nitrogen at surgery

26 EPIC-FLORENCE: STAFF PI Domenico Palli, MD, MPH Investigators: Giovanna Masala, MD, MPH Calogero Saieva, MD, MPH Statisticians: Res.Nurses: Dietician: Technician: Melania Assedi Marco Ceroti Donata Tanzini Donatella Zagni Ilaria Ermini Antonella Asta Collaborators: Benedetta Bendinelli Elena Gelain