Date post: | 29-Mar-2015 |
Category: |
Documents |
Upload: | madalynn-truitt |
View: | 220 times |
Download: | 1 times |
Organization and Communication:
The Women’s Environment, Cancer and Radiation Epidemiology
(WECARE) Study
Jonine Bernstein, Ph.D.
WECARE Study Overview
PurposeTo examine the interaction of radiation exposure and genetic
susceptibility in the etiology of second primary breast cancer.
HypothesisA 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.
DesignPopulation-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 population-based 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
Coriell DCS USC MSKCC
DCS SEER Sites
USC FHCRC UCI IOWA
BRI NRH USC LUND UCLA MSSM
UTMDACCVU
NYU
USCMSKCC
USM
WECARE Study Working Groups: WECARE Study Working Groups: Field OrganizationField Organization
Laboratories
Data Collection Centers
Coordinating Center
Epidemiological/Biostatistical Methods
Radiation Dosimetry
Cell Line Prep/Biorepository
External Advisory
Committee
NCI Program Officer
Data Management
MSKCC
Internal Advisory
WECARE Study Working SubcommitteesWECARE Study Working Subcommittees
Data & Biorepository Use
Rotating Membership
Publications
Rotating Membership
Allocation of Specimens and
Lab Protocol Review
Fixed Membership
Steering CommitteeAll PIs and Key Investigators
Internal Advisory
Fixed Membership
Data Analysis
Centrally Coordinated/All invited
Budget
Fixed Membership
Derived Variables
Centrally Coordinated/All Invited
WECARE Study Collaborative GroupCoordinating CenterJonine Bernstein MSKCC
Xiaolin Liang MSKCC
Abigail Wolitzer MSKCC
Internal AdvisorsLeslie Bernstein
Robert Haile
Pat Conconnan
WD Thompson
Data CollectionLeslie Bernstein USC
Laura Donnelly USC
Valerie Zayas USC
Kathy Lane USC
Jane Sullivan-Halley USC
Jorgen Olsen DCS
Lene Mellemkjaer DCS
Helle Clement Petersen DCS
Lisbeth Bertelsen DCS
Michael Andersson DCS
Kathleen Malone FHCRC
Noemi Epstein FHCRC
Heather Jurado FHCRC
Hoda Anton-Culver UCI
Joan Largent UCI
Kay Bergdahl UCI
Chuck Lynch Iowa
Jeanne DeWall Iowa
Lori Odle Iowa
MethodsDuncan Thomas USC
W. Douglas Thompson USM
Bryan Langholz USC
Xinbo Zhang USC
Yaping Wang USC
Colin Begg MSKCC
Marinela Capanu MSKCC
Amanda Hummer MSKCC
LaboratoryPat Concannon BRI
Sharon Teraoka BRI
Eric Olson BRI
Robert Haile USC
Anh Diep USC
Yong Liu USC
Nianmin Zhou USC
Shanyan Xue USC
Andre HernandezUSC
Evgenia Ter-Karapetova USC
Anne-Lise Borresen-Dale NRH
Laila Jasen NRH
Olaug Rodningen NRH
Ake Borg Lund
Therese Sandberg Lund
Lina Johansson Lund
Barry Rosenstein MSSM
David Atencio MSSM
Per Guldberg DCS
Radiation DosimetryMarilyn Stovall MDAAC
Susan Smith MDACC
Roy Shore NYU
RepositoryJeanne Beck Coriell
Rick Martinas Coriell
Anh Diep USC
Yong Liu USC
Irene Orlow MSKCC
ConsultantsRichard Gatti UCLA
Elaine Ostrander NIH
John Boice, Jr. VU
External AdvisorsAlice Whittemore Stanford
Jack Schull UTH
Bruce Ponder Cambridge
Program OfficerDaniela Seminara NCI
WECARE Study Communication
Communication
Through-out Study•Working Group Communication during field work-Constant
– 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.