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Study of Radiation Exposure and Bilateral Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00903591
Recruitment Status : Active, not recruiting
First Posted : May 18, 2009
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Translational Genomics Research Institute
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
NYU Langone Health
University of Chicago
University of California, Irvine
Stanford University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date May 15, 2009
First Posted Date May 18, 2009
Last Update Posted Date April 8, 2019
Actual Study Start Date May 2009
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00903591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 15, 2009)
  • Identify single nucleotide polymorphism that interact with radiation exposure. [ Time Frame: 2.5 years ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Radiation Exposure and Bilateral Breast Cancer
Official Title Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample or saliva sample
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).
Condition Breast Cancer
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: questionaire, blood or saliva sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 15, 2015)
1699
Original Estimated Enrollment
 (submitted: May 15, 2009)
800
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 54 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Denmark,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00903591
Other Study ID Numbers 09-040
R01CA129639-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators
  • Translational Genomics Research Institute
  • 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
  • NYU Langone Health
  • University of Chicago
  • University of California, Irvine
  • Stanford University
Investigators
Principal Investigator: Jonine Bernstein, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019