Biobanks associated to Cancer Screening Programs In Tuscany Francesca Carozzi. Analytical Cytology and Biomolecular Unit

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1 Biobanks associated to Cancer Screening Programs In Tuscany Francesca Carozzi Analytical Cytology and Biomolecular Unit

2 Bio-banks: Investments into Society The Public health care system is in great need of improvements in efficiency on all levels. The main strategy in developing bio-bank resources is to be able to improve on the prevention, diagnosis, as well as treatment of disease and to promote the health of the society Collecting bio-fluids within the frame of screening programs for cancer prevention forms the basis for bio-bank strategies where the search for an understanding of diseases at a molecular level is at focus.

3 Screening Programs in Italy A Screening Program is an intervention of Public Health, which consists of an organized path, for early diagnosis addressed to an asymptomatic population through an active call. The goal is to detect cancer at an early stage, when it is still very small and without symptoms. Any possible diagnostic and therapeutic care is also guaranteed and free of charge. CCM- *Raccomandazioni per la pianificazione e l esecuzione degli screening di popolazione per la prevenzione del cancro della mammella, del cancro della cervice uterina e del cancro del colon retto, 2006

4 Cancer Screening Programs with scientific evidence on their effectiveness provided at national level Breast cancer: mammography, women years, 2-year interval Cervical cancer: Pap smear, women from 25 to 60 years, 3 year interval Colo-rectal cancer: FOBT, men & women years, 2 year interval New Cancer Screening Programs in the evaluation phase : -Cervical Cancer : HPV-hr test, women >= 35 years -Colo-rectal cancer: Virtual colonoscopy/faecal DNA -Lung Cancer screening: Annual Low dose CT -Prostate Cancer

5 ISPO BIOBANK Biological samples from people partecipating in research studies within screening programs (cervix, colo-rectal, breast, lung, prostate cancers ) Sputum/ Bronchial brushings Blood Plasma Serum buffy coat Cervical Cells cervical mucus Urine Faecal DNA sample RNA Protein F.M. Carozzi 2011

6 Enrollment of subjects Invitation letter for screening program with information on opportunity to participate in the construction of the biobank donating biological samples At the screening center : signature of informed consent with the opportunity to ask questions relevant health Sampling of biological material for bio-banking in the context of the screening program

7 Bio-Bank: Development and management Standardization of sample collection, processing, storage and shipping The information on samples are collected in a study data base with restricted access Duplicates in different freeezers as a preventive measure of disaster Freezers with wireless alarm systems to alerts people in charge by sms messages The data base includes also information on the biobank location of aliquots and number of aliquots: total/used/available. Through a specific code assigned to each person it s possible to link the data base with screening data Screening data base can be linked to cancer and mortality registries and asos with SDO (hospital discharge cards )

8 Biobanks associated to the new strategies for lung cancer screening The experience of the ITALUNG randomised trial

9 Lung cancer screening Several preliminary studies in the US and Europe have showed promising results of screening for lung cancer with low-dose chest computed tomography (CT scan). The new technology has made possible to detect minimal small (>5cm) asymptomatic small nodules. The prognosis for those patients may be significantly improved compared to current patients with lung cancer, even those with Stage I disease However, whether or not early detection contributes to reduced lung cancer mortality is unclear today.

10 Lung Cancer screening trials and bio-banks The population-based trials of CT screening are a favourable environment in which to develop a collection of biological samples extremely useful reference material for many years to come. To evaluate efficiently recent advances in molecular screening and genotyping. To evaluate the inherited risk (SNPs) for the model refinement of the screening program

11 ITALUNG is a randomised controlled screening trial for lung cancer early detection with low-dose chest computed tomography (CT scan) ongoing in Tuscany, Italy. It is a multicentric, population-based recruitment trial to assess the efficacy of lung cancer screening with CT scan in reducing lung cancer mortality.

12 71232 Sent letter to patients through 269 MMG questionnaires (23.9%) ITALUNG BIOMARKERS RESEARCH PROJECT Subjects enrolled in the active arm of Italung trial were invited to donate BIOLOGICAL SPECIMENS Not elegible (81.2%) 3206 Elegible (18.8%) 1593 Randomised usual care group (49.7%) 1613 randomised active group (50.3%) 2 Questionnaire Biological specimens 1406 Ct scan performed at baseline (87.2%) 207 drop outs (12.8%)

13 Flow-chart Collecting specimens in Italung Biomarkers Project 1500 subjects CTscan screening CT Baseline Negative Blood, sputum At new screening round Annual repeat CT If new nodules Blood, sputum CT Baseline not calcified nodules Blood, sputum, Follow-up: 3,6,12 months Every CT Blood, sputum Bal, FNA, { Biopsy, Tumour tissue

14 Italung RCT Biomarker study- AOU Pisa ASL 3 Pistoia AOU Careggi All samples sent BIOBANK Centralized in Florence (ISPO) ITALUNG Biomarkers protocol A training was perfomed for standardization of sample collection, processing, storage Protocol/ Recommendations for EU-US CT-screening trials 96.4% of the ITALUNG subjects (active arm) gave consent to participate in the Biomarker study

15 Italung Questionnaire Interviewed administered questionnaire at enrollement Height at enrolment (cm) Weight at each visit (kg) Smoking Risks Specific questions for current and former smoker If interested in cessation programs/measure of nicotine dependence: (Recommended by the European Office of the World Health Organization) Occupational history Enviromental conditions Respiratory Problems Comorbidity Social and Economic Use of health services

16 Implementation Cervical BioBank Impact of HPV vaccination on screening for cervical cancer Grant by Tuscany Region/ITT Randomised clinical trial offering vaccination at the first call (25 years) of cervical cancer screening program

17 Effective surveillance and impact of HPV vaccination on screening for cervical cancer in Tuscany At baseline. - Cervical sample 832 enrolled (68.8%) 1208 presented at screening center - Urine sample - Blood sample At the next screening round. Cervical sample Blood sample Women invited by personalised letter

18 Biobanking within Cancer Screening Programs.. Within organised screening programs it is possible to organize a systematic bio-banking of biological specimens. By registry linkages, it is possible to track all health care events in large trial cohorts for decades after the Enrollment have been completed

19 Thanks for the attention!!