Actively Recruiting
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Led by University of Chicago · Updated on 2026-04-27
400
Participants Needed
1
Research Sites
500 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
CONDITIONS
Official Title
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known carrier of BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1, or STK11 mutations, or high polygenic risk score with other cancer susceptibility genes
- Lifetime breast cancer risk of 30% or higher based on genetic and non-genetic factors
- 5-year breast cancer risk of 6% or higher for women aged 40 and older with specific breast density and lifetime risk thresholds
- History of chest wall radiation before age 35
- Women of African ancestry under 45 with family history of breast or ovarian cancer
- At least 25 years old
- Willing to travel to study sites for imaging and follow-up
- Able to give informed consent
- Prior breast or ovarian cancer patients eligible if cancer-free for two years after completing treatment
You will not qualify if you...
- Undergoing active cancer treatment at enrollment
- Currently pregnant or planning pregnancy within two years
- Presence of pacemaker or metallic foreign object interfering with MRI
- Breast surgery within two weeks before study entry
- History of bilateral mastectomy
- History of kidney disease or abnormal kidney function
- Known dye allergy unless managed with medication
- Use of hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, PARP inhibitors, or participation in chemoprevention trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Cancer Clinical Intake Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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