Benign Breast Disease Clinical Trial
Official title:
Genetics of Mammographic Appearances and Patterns (The GenMap Study)
High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer
apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the
variation in density is attributable to common genetic factors. However, to date, efforts to
identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al
Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants
of density is related to a failure to study younger women and misclassification of density.
As women age, their breast tissues undergo atrophy, which is manifested radiologically as a
decrease in mammographic density, resulting in a convergence of density values and a masking
of inter-person variation. This protocol is intended to demonstrate the feasibility of
methods that we plan to use in a full-scale analysis of mammographic density among women
under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care
(FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS).
The Hormonal and Reproductive Epidemiology Branch (HREB) is currently conducting a
cross-sectional study entitled, Breast Radiology Evaluation and Study of Tissues (BREAST)
Stamp Project which aims to understand why mammographically dense tissues are related to
elevated breast cancer risk. This project is being conducted within the VBCSS using breast
cancer awareness Stamp Act funds. The BREAST Stamp project has focused on women between the
ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an
abnormality identified on a screening mammogram. The study has successfully enrolled over 400
women with collection of questionnaires, buccal and blood samples, and tissues. The study
will continue recruiting through May 2010, with a targeted enrollment of 450-500 women.
Through the infrastructure developed for the BREAST Stamp Project, mammographic volumetric
density data, assessed using a novel method with density phantoms developed at UCSF, has been
collected on approximately 25,000 screened women of all ages from February 2008-present.
The current protocol describes a study in which we propose to capitalize on infrastructure
that has been established through the BREAST Stamp Project. We propose to perform this study
in two phases: Phase one will be a feasibility study: specifically, we propose to demonstrate
that we can use a mailing to collect Oragene tube format saliva collection kits as a source
of germline DNA and a short self-administered questionnaire. This collection of specimens and
data will be used to inform the launch of phase two, the full-scale study to identify
determinants of mammographic volumetric density among approximately 10,000 women less than 50
years of age for whom raw images and density data are already collected. During the first
phase we hope to demonstrate feasibility by achieving at least 60% participation with
unbiased representation of subjects with regard to demographics and volumetric density
measurements. Once feasibility of this approach is established, we propose to launch the
full-scale study by contacting the remaining (approximately 10,000) women with existing
volumetric density data to collect questionnaires and DNA samples necessary to delineate the
genetic determinants of mammographic density, as well as to investigate hypothesized risk
factors for mammographic density and breast cancer risk, such as alcohol intake, cigarette
smoking, and breastfeeding history.
High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer
apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the
variation in density is attributable to common genetic factors. However, to date, efforts to
identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al
Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants
of density is related to a failure to study younger women and misclassification of density.
As women age, their breast tissues undergo atrophy, which is manifested radiologically as a
decrease in mammographic density, resulting in a convergence of density values and a masking
of inter-person variation. This protocol is intended to demonstrate the feasibility of
methods that we plan to use in a full-scale analysis of mammographic density among women
under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care
(FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS).
The study capitalizes on infrastructure that has been established through the BREAST Stamp
project that is being carried out in two phases: phase one is a feasibility study:
specifically, we propose to demonstrate that we can use a mailing to collect Oragene tube
format saliva collection kits as a source of germline DNA and a short self-administered
questionnaire. We have completed the phase one feasibility portion of the protocol, which
targeted 200 women by mail. As of January 25, 2011, of the 200 that were mailed invitations,
195 women were contacted (5 subjects forms were returned because of bad addresses), and 106
women enrolled. We are currently analyzing data from this feasibility study to determine
participation rates, quality of completed questionnaires and saliva samples, and frequencies
and distributions of key risk factors and demographics of participants. This collection of
specimens and data will be used to inform the launch of phase two, the full-scale study to
identify determinants of mammographic volumetric density among 10,000 women less than 50
years of age for whom raw images and density data are already collected.
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