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High Risk Breast Clinic: Understanding Your Breast Cancer Risk

This observational study is for women aged 30 to 65 who have at least twice the normal risk of developing breast cancer. The goal is to better understand and predict breast cancer risk by looking at various factors. Researchers will examine existing risk markers like cell changes from a random periareolar fine needle aspiration (RPFNA), mammogram density, and hormone levels. They will also explore new markers in breast tissue and genetic factors. The study aims to follow participants over time to see who develops breast cancer. The planned enrollment is 3000 women, but the current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 3000 women. It is not a treatment study, but rather focuses on understanding risk factors.
What's involved
You would need to have a mammogram within six months before an RPFNA. The study will collect demographic data and biological specimens.
Compensation
Not stated in the trial record.
Follow-up
The study plans to maintain contact with participants and follow them prospectively for the development of breast cancer.

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NCT00291096

High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

Recruiting
Not specifiedAges 30–65Observational
Carol Fabian, MD
~3,000 participants
Updated 2025-10-29 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prediction of risk for developing breast cancer
Measured over ongoing

Conditions

Breast Cancer

Explore related trials

Breast AtypiaBreast CarcinomaBreast Ductal Hyperplasia

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Carol J Fabian, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Bruce Kimler, Ph.D.
[email protected]
913-588-4523
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

women with at least 2 times the normal risk of developing breast cancer
between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
greater than six months from ingestion of antihormonal therapy
greater than 1 year from pregnancy, lactation, or chemotherapy
willing to have a mammogram within six months prior to RPFNA
willing to discontinue NSAIDS or herbal supplements
willing to have blood drawn

Exclusion

no metastatic malignancy of any kind
no breast implants or tram flap reconstructions
no radiation to both breasts
no women who have a current mammogram or clinical breast exam suspicious for cancer

What this trial measures

  • Prediction of risk for developing breast cancerongoing

    development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.