CompletedNot Applicable

Breast Mammogram and Tissue Study

United States466 participantsStarted 2007-05-11

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of collecting data needed

Timeframe: Dec. 2022

Trial details

NCT IDNCT00475761

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Breast Neoplasms trials