Study of Radiation Exposure and Bilateral Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Translational Genomics Research Institute, Phoenix, Arizona.
University of Southern California
University of Virginia
Lund University
Ontario Cancer Registry (OCR) and Mount Sinai Hospital- Toronto (MSHT)
Northern California Cancer Center
Fred Hutchinson Cancer Research Center
University of Iowa
Danish Cancer Society
Beckman Research Institute
City of Hope National Medical Center
M.D. Anderson Cancer Center
Vanderbilt University School of Medicine
New York University School of Medicine
University of Chicago
University of California, Irvine
Stanford University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00903591
First received: May 15, 2009
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.


Condition Intervention
Breast Cancer
Other: questionaire, blood or saliva sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify single nucleotide polymorphism that interact with radiation exposure. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood sample or saliva sample


Estimated Enrollment: 800
Study Start Date: May 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
All women will be interviewed by telephone using the a similar questionnaire as used in the parent study. DNA samples will be obtained either via blood samples drawn during a home or clinic visits, or an Oragene Saliva DNA Self-Collection Kit sent to the participant's home.
Other: questionaire, blood or saliva sample
Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them.
Other Names:
  • The women who consented to 'future contact' in the WECARE:GWAS Study will be
  • identified, approached, and interviewed by investigative teams in the five data collection sites
  • (CPIC, MSHT, FHCRC, Iowa, and DCS) over approximately 8 months. Across all data
  • collection sites, we will approach all eligible cases and controls who consented to future contact
  • and request participation in the follow-up study to complete the structured questionnaire either
  • via mail or telephone.

Detailed Description:

This study expands upon an existing case-control study we call the Women's Environment Cancer and Radiation Epidemiology (WECARE) Study. For simplicity, in this protocol, we will refer to that study as the "parent" study. The goal of both studies is to examine the interaction of radiation exposure and genetic susceptibility factors in the etiology of breast cancer. A subset of study participants who consented to 'future contact' in the GWA Study (and those in the 'parent' study from selected sites) will be included in an analysis of radiation-related heart disease and related conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All of the WECARE:GWA Study participants (new cases and individually matched controls) will be identified, recruited, and interviewed by investigative teams in the five population-based cancer registries (NCC, OCR, FHCRC, Iowa, and DCS).

Criteria

Inclusion Criteria:

  • Eligibility for Cases: All women who meet the following eligibility requirements will be recruited as cases for the WECARE:GWA Study if they are not already cases (or refusers) from the parent WECARE Study:
  • Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (cancer registry);
  • Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same enrollment site (cancer registry);
  • Two years or longer time interval between first and second primaries; Between the ages of 18 and 54 at the time of diagnosis of the first primary;
  • Alive at time of contact; and
  • No history of previous or intervening cancer diagnosis, except cervical cancer in situ (CIS) or non-melanoma skin cancer.
  • Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.

Eligibility for Controls: Women who meet all of the following requirements will be eligible as controls. One matched control will be recruited for each participating case:

  • Diagnosed since 1/1/1990 with their first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (i.e., cancer registry);
  • Between the ages of 18 and 54 at the time of diagnosis of the first primary;
  • Residing in the same study enrollment site (cancer registry) as when they were diagnosed with their breast cancer;
  • Alive at time of contact;
  • Never diagnosed (at reference date (date of first diagnosis plus "at risk interval" of matched case)) as having had CBC or any other cancer diagnosis other than the original breast cancer; with the exception of CIS or non-melanoma skin cancer.
  • Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.

Matching of Controls: Controls eligible for inclusion in this study will be individually matched (1:1) to cases on:

  • Enrollment site (cancer registry);
  • Age at diagnosis of the cases first primary(within 5-year age groups);
  • Year of diagnosis of the cases first primary;(within 4-year categories);
  • Race/ethnicity (white, black, Latina, Asian, other).

Exclusion Criteria:

Exclusion for Cases: Women with any of the following characteristics will be ineligible as a case:

  • Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the California site, and Danish in Denmark
  • Unable to sign informed consent
  • Stage IV distant metastases for either the first or second primary (lymph node metastasis is acceptable, but there should be no organ involvement
  • Simultaneous diagnosis of invasive in one breast and in situ in the other breast

Exclusion for Controls: Women with any of the following characteristics will be ineligible as a control:

  • Unable to speak English in U.S. and Canadian enrolling sites, or Spanish in the California site and Danish in Demark
  • Unable to sign informed consent
  • Stage IV distant metastases (lymph node metastasis is acceptable, but there should be no organ involvement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903591

Contacts
Contact: Jonine Bernstein, PhD 646-735-8155

Locations
United States, California
Cancer Prevention Institute of California Recruiting
Fremont, California, United States, 94538
Contact: John Esther, PhD       esther.john@CPIC.org   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Charles Lynch, MD, MS, PhD    319-384-5006      
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jonine Bernstein, PhD    646-735-8155      
Contact: Colin Begg, PhD         
Principal Investigator: Jonine Bernstein, PhD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Kathleen Malone, PhD    206-667-4632      
Canada
Ontario Cancer Registry-Fu Study Recruiting
Ontario, Canada
Contact: Julia Knight, PhD         
Principal Investigator: Julia Knight, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Translational Genomics Research Institute, Phoenix, Arizona.
University of Southern California
University of Virginia
Lund University
Ontario Cancer Registry (OCR) and Mount Sinai Hospital- Toronto (MSHT)
Northern California Cancer Center
Fred Hutchinson Cancer Research Center
University of Iowa
Danish Cancer Society
Beckman Research Institute
City of Hope National Medical Center
M.D. Anderson Cancer Center
Vanderbilt University School of Medicine
New York University School of Medicine
University of Chicago
University of California, Irvine
Stanford University
Investigators
Principal Investigator: Jonine Bernstein, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00903591     History of Changes
Other Study ID Numbers: 09-040, R01 CA129639-01A2
Study First Received: May 15, 2009
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
cancer
09-040
blood sample
saliva sample
WECARE
GWA

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014