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Organization and Communication: The Women’s Environment, Cancer and Radiation Epidemiology (WECARE) Study Jonine Bernstein, Ph.D. WECARE Study Overview Purpose To examine the interaction of radiation exposure and genetic susceptibility in the etiology of second primary breast cancer. Hypothesis A woman who carries a mutant variant in one of the genes under study will be more susceptible to radiation-induced cancer than a woman who is not a carrier. Design Population-based, case-control study – Cases are women with bilateral breast cancer – Controls are women with unilateral breast cancer (Bernstein, … , Thompson, Br Ca Res 2004) Data Sources WECARE Study Design Cases (n=708) • Diagnosed since 1/1/1985 with incident breast cancer • Diagnosed since 1/1/1986 with contralateral breast cancer • One year or longer time lag between primaries • Under age 55 at diagnosis of the first primary • No other cancer diagnosis • Alive WECARE Study Design Controls (n=1397) • With unilateral breast cancer • Individually matched 2:1 to cases on: – Registry – Age (5 year) – Diagnosis date of breast cancer (4 year) – Race • No other cancer diagnosis • Counter-matched on radiotherapy status – 2:1 (RRT+: RRT -) WECARE Study Data Collection • Women identified through 5 populationbased cancer registries (US and Denmark) • Telephone interview using a structured questionnaire • During home visits, a blood sample drawn by a study phlebotomist Medical Treatment Information and Data for Radiation Dosimetry • Sources – Treatment and tumor characteristics information collected registry records – Hospital charts – Pathology/surgery reports – Doctor office /mammography records – Radiation oncology files • Missing Data – ~ 7% patient records inadequate for dosimetry – ~ 2% participants have all documentation missing Contralateral Breast Dose (cGy): Mean and Range among Patients Treated with Breast Irradiation (1488 patients) Laboratory Screening • Genetic Analyses – Conducted in 5 labs for all 2100 WECARE Study participants (US, Norway, and Sweden) – Staged approach: DHPLC followed by direct sequencing – All conditions, primers standardized across labs – Inter- and Intra-lab QC implemented (Bernstein, … , Concannon, Hum Mut 2003) WECARE Study Organization WECARE Study Working Groups: Field Organization Laboratories Data Collection Centers DCS SEER Sites USC FHCRC UCI IOWA BRI USC UCLA NRH LUND MSSM Coordinating Center External Advisory Committee NCI Program Officer Internal Advisory Radiation Dosimetry Epidemiological/ Biostatistical Methods USC MSKCC USM UTMDACC VU NYU Cell Line Prep/Biorepository Coriell DCS USC MSKCC Data Management MSKCC WECARE Study Working Subcommittees Data & Biorepository Use Publications Rotating Membership Rotating Membership Allocation of Specimens and Lab Protocol Review Fixed Membership Steering Committee All PIs and Key Investigators Internal Advisory Data Analysis Centrally Coordinated/All invited Fixed Membership Budget Derived Variables Fixed Membership Centrally Coordinated/ All Invited WECARE Study Collaborative Group Methods Coordinating Center Jonine Bernstein MSKCC Xiaolin Liang MSKCC Abigail Wolitzer MSKCC Radiation Dosimetry Duncan Thomas USC Marilyn Stovall MDAAC W. Douglas Thompson USM Susan Smith MDACC Bryan Langholz USC Roy Shore NYU Xinbo Zhang USC Yaping Wang USC Colin Begg MSKCC Pat Conconnan Marinela Capanu MSKCC WD Thompson Amanda Hummer MSKCC Internal Advisors Leslie Bernstein Robert Haile Data Collection Laboratory Repository Jeanne Beck Coriell Rick Martinas Coriell Anh Diep USC Yong Liu USC Irene Orlow MSKCC Leslie Bernstein USC Laura Donnelly USC Pat Concannon BRI Valerie Zayas USC Sharon Teraoka BRI Kathy Lane USC Jane Sullivan-Halley USC Eric Olson BRI Jorgen Olsen DCS Robert Haile USC Anh Diep USC Yong Liu USC Nianmin Zhou USC Shanyan Xue USC External Advisors Lene Mellemkjaer DCS Helle Clement Petersen DCS Lisbeth Bertelsen DCS Consultants Richard Gatti UCLA Elaine Ostrander NIH John Boice, Jr. VU Michael Andersson DCS Kathleen Malone FHCRC Noemi Epstein FHCRC Andre Hernandez USC Alice Whittemore Stanford Heather Jurado FHCRC Evgenia Ter-Karapetova USC Jack Schull UTH Hoda Anton-Culver UCI UCI NRH Cambridge Joan Largent Anne-Lise Borresen-Dale Bruce Ponder Kay Bergdahl UCI Laila Jasen NRH Chuck Lynch Iowa Olaug Rodningen NRH Jeanne DeWall Iowa Ake Borg Lund Program Officer Lori Odle Iowa Therese Sandberg Lund Daniela Seminara Lina Johansson Lund Barry Rosenstein MSSM David Atencio MSSM Per Guldberg DCS NCI WECARE Study Communication Communication Through-out Study •Working Group Communication during field workConstant – Within Group • Bi-monthly conference calls • Monthly data delivery and progress reports • Dedicated web-site – Between Group • Annual/ semi-annual key investigator meetings Central Informatics Management System Functional domains – Tracking database – every phase and every aspect of study on individual level and triplet level – Database for storage, cleaning and maintain data acquired through data collection instruments – Mutation screening database – screening process and results – Long term storage and access – Secures confidentiality CIMS links and maintains data from all sources and tracks all information so it is instantly available. Tracking database -Data Collection Production Report 1 WECARE Study Informatics WECARE Study Informatics WECARE Study Informatics WECARE Study Informatics Summary: Challenges • Study set up is key– anticipate the type of informatics that will be needed and plan ahead; • Involve trained personnel, including informatics specialists, data managers and editors (for both lab and epi data); •Over-communicate throughout the study, especially if the study involves scientists from diverse geographic regions; • Plan in advance to maintain the infrastructure, even as the study is winding down.