Clinical trial NCT00903591: Study of Radiation Exposure and Bilateral Breast Cancer
Official title: Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast
cancer
09-040
blood sample
saliva sample
WECARE
GWA
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
name: University of Southern California
name: University of Virginia
name: Lund University
name: Ontario Cancer Registry (OCR) and Mount Sinai Hospital- Toronto (MSHT)
name: Northern California Cancer Center
name: Fred Hutchinson Cancer Center
name: University of Iowa
name: Danish Cancer Society
name: Beckman Research Institute
name: City of Hope National Medical Center
name: M.D. Anderson Cancer Center
name: Vanderbilt University School of Medicine
name: NYU Langone Health
name: University of Chicago
name: University of California, Irvine
name: Stanford University
First posted: 2009-05-18
Enrollment: 1699
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.
timeFrame: 2.5 years
Secondary outcomes:
measure: Identify single nucleotide polymorphism that interact with radiation exposure.
timeFrame: 2.5 years
measure: 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.
timeFrame: 2.5 years
measure: 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.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Toronto
country: Canada
facility: ONTARIO CANCER REGISTRY, Mount Sinai Hospital, Toronto
state: Ontario
city: København
country: Denmark
facility: Danish Cancer Society
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonine Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: