NCT00475761

Brief Summary

Background: 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. Objectives: 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. Eligibility: 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. Design: 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

April 20, 2026

Status Verified

January 30, 2026

First QC Date

May 18, 2007

Last Update Submit

April 17, 2026

Conditions

Breast Neoplasms

Keywords

Breast biopsyBreast imagingBreast CancerMammographic DensityNatural History

Outcome Measures

Primary Outcomes (1)

  • Feasibility of collecting data needed

    Feasibility of collecting data needed from pilot to report the preliminary results from the pilot data in published manuscripts.

    Dec. 2022

Study Arms (1)

Breast Cohort

Primary clinical- patients referred to diagnostic breast biopsy

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary clinical- patients referred to diagnostic breast biopsy due to an abnormal breast imaging exam.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (3)

  • Gierach GL, Patel DA, Pfeiffer RM, Figueroa JD, Linville L, Papathomas D, Johnson JM, Chicoine RE, Herschorn SD, Shepherd JA, Wang J, Malkov S, Vacek PM, Weaver DL, Fan B, Mahmoudzadeh AP, Palakal M, Xiang J, Oh H, Horne HN, Sprague BL, Hewitt SM, Brinton LA, Sherman ME. Relationship of Terminal Duct Lobular Unit Involution of the Breast with Area and Volume Mammographic Densities. Cancer Prev Res (Phila). 2016 Feb;9(2):149-58. doi: 10.1158/1940-6207.CAPR-15-0282. Epub 2015 Dec 8.

    PMID: 26645278BACKGROUND

  • Gierach GL, Geller BM, Shepherd JA, Patel DA, Vacek PM, Weaver DL, Chicoine RE, Pfeiffer RM, Fan B, Mahmoudzadeh AP, Wang J, Johnson JM, Herschorn SD, Brinton LA, Sherman ME. Comparison of mammographic density assessed as volumes and areas among women undergoing diagnostic image-guided breast biopsy. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2338-48. doi: 10.1158/1055-9965.EPI-14-0257. Epub 2014 Aug 19.

    PMID: 25139935BACKGROUND

  • Horne HN, Sherman ME, Pfeiffer RM, Figueroa JD, Khodr ZG, Falk RT, Pollak M, Patel DA, Palakal MM, Linville L, Papathomas D, Geller B, Vacek PM, Weaver DL, Chicoine R, Shepherd J, Mahmoudzadeh AP, Wang J, Fan B, Malkov S, Herschorn S, Hewitt SM, Brinton LA, Gierach GL. Circulating insulin-like growth factor-I, insulin-like growth factor binding protein-3 and terminal duct lobular unit involution of the breast: a cross-sectional study of women with benign breast disease. Breast Cancer Res. 2016 Feb 18;18(1):24. doi: 10.1186/s13058-016-0678-4.

    PMID: 26893016BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gretchen L Benson, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 21, 2007

Study Start

May 11, 2007

Last Updated

April 20, 2026

Record last verified: 2026-01-30

Locations

US(1)