NCT00291096 · Carol Fabian, MD
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
What this study is about
The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.
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The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.
Primary outcome measures
Prediction of risk for developing breast cancer
Time frame: ongoing
development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Kansas City, Kansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations