Translational cancer research is highly dependent on having large series of cases with high-quality samples that were collected, processed, stored and annotated in a systematic fashion according to international standards, such as the ISBER Best Practices for Biorepositories. Sharing successful strategies between the Baylor College of Medicine (BCM) Cancer Center and Breast Center Buenos Aires (BCBA), we created this Argentinean biobank complete with breast cancer-oriented data, tumor and normal breast tissue and matched blood specimens according to best practices to facilitate international collaborative translational breast cancer research. Objective: Creation of a blood, breast tissue and tumor biobank in Argentina for research purposes with associated epidemiological, pathological, clinical, and follow-up data. Methods: Consented individuals from BCBA are classified by treating physician in four categories: 1) breast cancer; 2) benign breast disease by biopsy; 3) high-risk for breast cancer according to the Gail Model; and 4) healthy controls. Blood is collected at several time points during the breast cancer disease process: pre-surgical, pre-systemic treatment, and, if applicable, in the metastatic setting. Blood products are stored as whole blood, plasma, buffy coat, red blood cell pellet, serum and clot at −80°C or at room temperature in GenPlates. Fresh tissue and tumor sample is collected during surgical or core biopsy proceedings and stored at −80°C and paraffin embedded. Upon enrollment, participants complete an extensive epidemiological and risk factor questionnaire, which is supplemented by medical record abstraction for relevant pathological and clinical data. Participants are also re-contacted once a year for follow-up. The creation of this biobank in 2009 included the preparation and adaptation of the following processes from the Population Science Biorepository and Smith Breast Center Tumor Bank at BCM, including: 1) IRB-approved informed consent documents with specific language relevant to DNA-based research; 2) Epidemiological and risk factor questionnaires (10-page Core module and 6-page Breast module); 3) Blood and tissue collection protocols, sample processing, sample bar coding and participant/sample registration system; and 4) Web-based data management system, specifically designed for this biobank with encryption and data security (details presented in a separate abstract), including role-based access levels personal health information. Conclusion: We started our endeavor in August 2008. The development of the consent forms, two questionnaires, and biobank database prototype took one year at BCM. The translation of consents and questionnaires into Argentinean Spanish took an additional 3 months. Overall the Argentinean IRB approval process, training personnel, and equipment set-up lasted for 14 months. By April 2011, the first Argentinean participant was consented into the biobank. It took nearly 3 years from inception to realization for this biobank; however, the potential benefit to translation breast cancer research is large. The overall value of this biobank will depend on the number of individuals/samples accrued and the number of years of follow-up attained. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-16-03.

The quality of biospecimens and associated data accuracy in a Biobank must be collected and consistent according to standardized methods in order to achieve international harmonization and coordination among biobanking networks. Sharing successful strategies between the Baylor College of Medicine (BCM) Breast and Cancer Centers and Breast Center Buenos Aires (BCBA) was the fundamental stone for the creation of an Argentinean Breast Cancer oriented Biobank with a shared data management system. We have designed, developed and implemented a computer system to easily manage sensible associated data. This innovative system, allows the data entry in a visual, intuitive, friendly and orderly way, integrating all the information for further analysis and easy use of samples for translational research. Objective: Develop and improve (v2.0) a bilingual web-based tool for biospecimen management, inventory, clinical and breast cancer data registration according with international standards of data security quality assurance and ISBER Best Practices for Biorepositories. Methods: System Characteristics: Multi-tier architecture, relying on a SQL server 2008 R2 data base. Operating System: Windows Server Series. Programmer Language .net 4.0 C#.. The system operates with Internet Explorer as flat client or similar. Bilingual English/Spanish system, fully configurable by modules, HIPPA compliant sensible data confidentiality, with de-identification of samples through 2D bar codes. Results : System Capabilities and Improvements v2.0: • Security Module: Allows to manage predetermined profiles (Clinical Research Coordinator Clinical staff as Phlebotomist, Pathologist, PA, MDs, PhDs, Researchers), audit controls implemented through permits according to the profile. • Master Tables: allows to insert/add/change data associated into master tables, providing system user independence. • General Registration Module: Online statistics allows to see immediately the number of consented individuals, types of samples and their classification. • Sample Management: Assigns unequivocally identification of each sample in a 2D bar code for freezer lab labels(LabExpert®). Has online statistical information on the number of samples and tubes used, for an easy supply management. Automatically assigns the location of samples per product type in the freezer. Allows to know the occupancy rate online. • Breast Cancer Module: A comprehensive data base in an attractive visual environment of eight screens: Clinical data, Biopsy, Definitive Surgery, Systemic Treatment, Radiation Treatment, Cancer Events, follow up and Summary screen. Includes path reports and sample collection forms attached in each corresponding biopsy or surgery screen for easy view and data entry quality assurance. Conclusion: This Biobank Management System was designed in a friendly and intuitive data entry environment by a multidisciplinary team including breast surgeons, pathologists, oncologists, statisticians, system engineers and programmers from BCM and BCBA. It could be adapted to be used in full or in separate modules by Breast Centers and Breast Cancer Oriented Biobanks. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-19-04.

The quality of biospecimens and associated data must be consistent and collected according to standardized methods in order to achieve international harmonization and coordination among biobanking networks. Sharing successful strategies between the Baylor College of Medicine (BCM) Cancer Center and Breast Center Buenos Aires (BCBA) is the driving force for the creation of an Argentinean Breast Cancer oriented Biobank with a shared data management system. Objective: To create a bilingual web-based tool for biospecimen management, inventory, clinical and breast cancer data registration according to international standards of data security quality assurance (ISO 27001). Methods/System Characteristics: The system permits users to enter and retrieve data concerning the collection, storage, quality assurance and distribution of biospecimens, and provides clinical and other patient data for samples while maintaining strict patient confidentiality. It has a multi-tier architecture, developed using Service-Oriented Architecture (SOA) software design principles in .net 4.0, and uses a SQL server database backbone. The system allows multidimensional data analysis trough On Line Analytical Processes (OLAP) and operates with standard web clients, such as Internet Explorer. User Profiles/Access Levels: Clinical staff (e.g., clinical research coordinator, phlebotomist, pathologist, PA, MD) conduct participant and consent registration and preregistration, epidemiological questionnaire data entry, barcode label generation, form printing, and clinical and pathological cancer data entry.Biospecimen resource staff (e.g., lab technicians) track and store data about biospecimen collection, inventory, tracking and distribution, generate sample barcode labels, and maintain sample allocation and freezer maps for the system.Scientists have the ability to search for biospecimens and associated data for their own translational research projects. Breast Cancer Database: Detailed clinical, pathological, treatment and follow-up breast cancer information are captured for each patient, including TNM, biopsy and definitive surgery of primary tumor and events, systemic and radiation treatment, recurrences and metastasis, follow-up. A summary screen provides a snapshot of these data to the viewer. Pathology reports and sample collection forms are attached in each corresponding biopsy or surgery screen for easy viewing and quality assurance. Conclusion: This Biobank Management System was designed by a multidisciplinary team to improve and streamline the workflow for each member of the biobank by: allowing preregistration capabilities before consenting individuals or collecting samples, automatic generation of clinical and sample ID labels, and real-time statistics with certified secure sensible information confidentiality. This system's value is its wide range of uses, from the day-to-day management of a multicenter biobank to the storage of detailed clinical cancer-related data in a user-friendly and intuitive data entry environment. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-16-02.

Four years ago, after our Baylor College of Medicine (BCM) Breast and Cancer Centers experience, we decided to initiate a related translational research Project at the Breast Center Buenos Aires (BCBA) in Argentina. This included the development of a breast cancer-oriented Management System for clinical and lab data attached to a biorepository of tumor and normal breast tissue with matched blood specimens. We strictly followed ISBER Best Practices for Biorepositories, and shared the same protocols and strategies with BCM to facilitate international collaborative breast cancer research, being extremely aware of international standards. Objectives: Creation of a breast cancer-oriented blood, breast tissue and tumor biobank for translational research purposes. Creation of a Biobank Management and Tracking System, with a breast cancer database for associated epidemiological, pathological, clinical, and follow-up data of each patient. Methods: From April 2011 to June 2013 we processed blood and tissue samples from BCBA. Blood is collected at several time points during the breast cancer disease process: pre-surgical, pre-systemic treatment, and, if applicable, in the metastatic setting. Blood products are stored as whole blood, plasma, buffy coat, red blood cell pellet, serum and clot at -80°C or in GenPlates®. Fresh tissue and tumor samples were collected during surgical or core biopsy proceedings and stored fresh at -80°C in 1 ml cryovials and as FFPE (formalin-fixed paraffin embedded) tissue. Upon enrollment, participants completed an extensive epidemiological and risk factor questionnaire, which is supplemented by medical record abstraction for relevant pathological and clinical data, and re-contacted once a year for follow-up. Preparation and adaptation processes were compliant with the Population Sciences Biorepository and Smith Breast Center Tumor Bank at BCM: 1) IRB-approved informed consent documents 2) Epidemiological and risk factor questionnaires (Core/Breast module); 3) Blood and tissue collection and processing protocols. A web-based data management and tracking system was specifically designed for the BCBA biobank. Results: To date, we have collected 9043 samples, from 274 individuals, in 293 sample collections. Of 5449 frozen samples, 5054 (92.7%) are blood and 395 (7.3%) are tissue. We also collected 3264 blood samples in GenPlate® wells from 68 patients on 17 plates, and extracted DNA from them into Gentegra® tubes, all stored at room temperature. 230 FFPE breast cancer tissue biopsies from 20 surgical specimens, given by the pathologist after diagnosis, stored in cassettes at room temperature in our lab, were also included in the system starting from January 2013. All of them have been classified by the physician into three categories: Healthy Control 15.3% (n = 42), Benign 55.1% (n = 151) and Cancer 29.6% (n = 81). We collected epidemiological, and cancer data from all of them in our system. Conclusion: It took nearly 4 years from inception to realization for this biobank; however, the potential benefit to translation breast cancer research is large. The overall value of this biobank will depend on the number of individuals/samples accrued, the follow-up attained and data accuracy. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-19-03.