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Organization and Communication: The W omen’s E nvironment, C ancer a nd R adiation E pidemiology (WECARE) Study PowerPoint Presentation
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Organization and Communication: The W omen’s E nvironment, C ancer a nd R adiation E pidemiology (WECARE) Study Jonine Bernstein, Ph.D. WECARE Study Overview . Purpose

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Organization and Communication: The Women’s Environment, Cancer and Radiation Epidemiology (WECARE) Study Jonine Bernstein, Ph.D.

wecare study overview
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)

wecare study design
WECARE Study Design

Cases (n=708)

  • Diagnosed since 1/1/1985 with incidentbreast 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 design1
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
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
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
slide8
Contralateral Breast Dose (cGy): Mean and Range among Patients Treated with Breast Irradiation (1488 patients)
laboratory screening
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)

slide11

USC

MSKCC

USM

UTMDACC

VU

NYU

WECARE Study Working Groups: Field Organization

DCS

SEER Sites

USC FHCRC

UCI IOWA

Laboratories

Data Collection Centers

BRI NRH

USC LUND

UCLA MSSM

Coordinating Center

NCI

Program Officer

External Advisory

Committee

Internal Advisory

Epidemiological/

Biostatistical Methods

Radiation Dosimetry

Cell Line Prep/Biorepository

Data Management

Coriell DCS

USC MSKCC

MSKCC

slide12

WECARE Study Working Subcommittees

Data &

Biorepository Use

Rotating Membership

Publications

Rotating Membership

Allocation of

Specimens and

Lab Protocol Review

Fixed Membership

Steering Committee

All 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 group
WECARE Study Collaborative Group

Coordinating Center

Jonine Bernstein MSKCC

Xiaolin Liang MSKCC

Abigail Wolitzer MSKCC

Internal Advisors

Leslie Bernstein

Robert Haile

Pat Conconnan

WD Thompson

Data Collection

Leslie 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

Methods

Duncan Thomas USC

W. Douglas Thompson USM

Bryan Langholz USC

Xinbo Zhang USC

Yaping Wang USC

Colin Begg MSKCC

Marinela Capanu MSKCC

Amanda Hummer MSKCC

Laboratory

Pat Concannon BRI

Sharon Teraoka BRI

Eric Olson BRI

Robert Haile USC

Anh Diep USC

Yong Liu USC

Nianmin Zhou USC

Shanyan Xue USC

Andre Hernandez USC

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 Dosimetry

Marilyn Stovall MDAAC

Susan Smith MDACC

Roy Shore NYU

Repository

Jeanne Beck Coriell

Rick Martinas Coriell

Anh Diep USC

Yong Liu USC

Irene Orlow MSKCC

Consultants

Richard Gatti UCLA

Elaine Ostrander NIH

John Boice, Jr. VU

External Advisors

Alice Whittemore Stanford

Jack Schull UTH

Bruce Ponder Cambridge

Program Officer

Daniela Seminara NCI

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
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.

summary challenges
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.