- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475761
Breast Mammogram and Tissue Study
Breast Radiology Evaluation and Study of Tissues (Breast) Stamp Project
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Breast Cohort
Primary clinical- patients referred to diagnostic breast biopsy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of collecting data needed
Time Frame: Dec. 2022
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Feasibility of collecting data needed from pilot to report the preliminary results from the pilot data in published manuscripts.
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Dec. 2022
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gretchen Benson, Ph.D., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999907150
- 07-C-N150
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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