Program for women at high risk of breast cancer
High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
University of Kansas Medical Center · NCT00291096
This study is testing a new program to help women at high risk of breast cancer by looking at different factors that might predict their chances of developing the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Kansas Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT00291096 on ClinicalTrials.gov |
What this trial studies
This project aims to create a comprehensive system for assessing breast cancer risk by analyzing various epidemiologic and biological factors. It will correlate established risk biomarkers, such as cytomorphology from fine needle aspiration and mammographic breast density, with long-term risk estimates. The study will also evaluate new potential biomarkers and genetic polymorphisms to enhance predictive capabilities for breast cancer development. Participants will be followed over time to gather data on their health outcomes and risk factors.
Who should consider this trial
Good fit: Ideal candidates are women aged 30-65 with at least double the normal risk of developing breast cancer.
Not a fit: Patients with current breast cancer, metastatic malignancies, or those with certain breast surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for women at high risk of developing breast cancer.
How similar studies have performed: Other studies have shown promise in using similar biomarker approaches for breast cancer risk assessment, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
Study contacts
- Principal investigator: Carol J Fabian, MD — University of Kansas Medical Center
- Study coordinator: Bruce Kimler, Ph.D.
- Email: bkimler@kumc.edu
- Phone: 913-588-4523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast atypia, fine needle aspiration, high risk for breast cancer, breast epithelial hyperplasia