Clinical trial · Observational
Breast Mammogram and Tissue Study
Breast Radiology Evaluation and Study of Tissues (Breast) Stamp Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cohort
- description
- Primary clinical- patients referred to diagnostic breast biopsy
Primary outcomes (1)
- measure
- Feasibility of collecting data needed
- timeFrame
- Dec. 2022
- description
- Feasibility of collecting data needed from pilot to report the preliminary results from the pilot data in published manuscripts.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDGierach 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 26645278
- BACKGROUNDGierach 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 25139935
- BACKGROUNDHorne 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 26893016