Actively Recruiting

Phase Not Applicable
Age: 25Years +
FEMALE
Healthy Volunteers
NCT03729115

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

Age: 25Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer | DecenTrialz