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Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer


N/A
18 Years
54 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

Jonine Bernstein, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-040

NCT ID:

NCT00903591

Start Date:

May 2009

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast
  • cancer
  • 09-040
  • blood sample
  • saliva sample
  • WECARE
  • GWA
  • Breast Neoplasms

Name

Location

University of IowaIowa City, Iowa  52242
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Cancer Prevention Institute of CaliforniaFremont, California  94538