Breast Mammogram and Tissue Study

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. Identifier: NCT00475761
Recruitment Status : Active, not recruiting
First Posted : May 21, 2007
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and to have cancers that are missed by mammograms.

It is unclear why some factors lead to having dense breasts and why having dense breasts increases the risk of developing breast cancer.


To determine why some women s breasts look dense on mammograms.

To determine what types of cells and tissues make up dense areas of breasts and why these tissues may be more likely to become cancerous.


Women between 40 and 65 years of age who have not had breast cancer or received medicines or radiation for any type of cancer and who are scheduled to undergo a breast biopsy.


This study is conducted at the University of Vermont, in collaboration with the NCI.

Participants undergo the following:

  • Review of their medical records collected over the last 2 years by the Vermont Mammography Registry.
  • Participation in a short telephone interview.
  • Height and weight measurement.
  • Testing of biopsy tissue collected for diagnosis or treatment.
  • Future contacts regarding health status for up to 10 years, including review of additional mammograms, removed tissues, questionnaires and medical records collected by the Vermont Mammography Registry during the 10-year study.

Participants may also undergo the following optional procedures:

  • Provide a mouthwash sample for genetic testing.
  • Provide a blood sample to test for markers of dense mammograms or breast cancer.

Condition or disease
Breast, Neoplasms

Detailed Description:
High breast density and aging are the strongest risk factors for sporadic breast cancer among women. Although glandular epithelium contributes to mammographic density, non-epithelial tissue components represent its major determinants: adipose tissue is radiolucent and fibrous tissue is dense. The hypothesis is that epidemiologic factors associated with elevated breast density alter the breast microenvironment (ME) (defined as all cells and structures surrounding luminal glandular cells including: myoepithelial cells; basement membrane, stromal fibroblast and myofibroblasts; endothelial cells and pericytes; inflammatory cells, collagens, matrix proteins, growth factors, hormones, and other biochemical components) in a manner that enhances dysregulated proliferation of breast epithelium and ultimately cancer. Specifically, the Investigators propose that epidemiologic factors that lead to increased exposure to hormones and inflammatory mediators alter the ME, leading to both increased breast density and cancer. The critical importance of the ME in carcinogenesis is supported by experimental and clinical data showing that epithelial abnormalities alone are generally insufficient for cancer development without concurrent changes in the ME. The primary aim of this pilot study is to demonstrate the feasibility of collecting the data needed to elucidate the biologic mechanisms that mediate the substantial breast cancer risk associated with high mammographic density. Specifically, the Investigators will develop, fine tune, and validate a complex cross-sectional study protocol to collect risk factor data and biological specimens (blood, buccal cells, tissue fluids, and tissue) required to discover mechanisms and biomarkers that link high mammographic density (as measured quantitatively using computerized methods) to breast cancer risk. They will enroll 250 women between the ages of 40 to 65 years undergoing a radiologically guided biopsy at the University of Vermont, the largest center within the Vermont Breast Cancer Surveillance System (VBCSS), to participate in this pilot study of mammographic density.

Study Type : Observational
Actual Enrollment : 466 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Radiology Evaluation and Study of Tissues (Breast) Stamp Project
Study Start Date : May 12, 2007

Primary Outcome Measures :
  1. Breast Cancer [ Time Frame: Enrollment ]
  2. Mammographic density [ Time Frame: Enrollment and over 10 years of follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria for participation in the study are women, ages 40-65 years of age, who are undergoing a radiologically-guided biopsy (stereotactic- ultrasound-guided). We will NOT exclude subjects for current or past use of exogenous hormones; prior hysterectomy or salpingoophorectomy or presentation with a breast mass. Although most biopsies are prompted by a radiologic finding (typically abnormal calcifications or masses), some biopsies are performed for symptoms that are unassociated with a radiologic finding, such as nipple discharge, palpable mass, discomfort, etc. Elevated density per se is not a biopsy indication. ALL women referred for radiologically guided biopsy, irrespective of the indication, will be considered eligible for the pilot study.


We will EXCLUDE women who have a prior history of breast cancer, have had an EXCISIONAL breast biopsy within one year, women who have implants in place, women taking tamoxifen or raloxifene for chemoprevention and women who have received non-surgical treatments for cancers of other organs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475761

United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Gretchen Benson, Ph.D. National Cancer Institute (NCI)