NCT03729115 · University of Chicago
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
(CAPS)
What this study 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.
View original scientific description
This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
Interventions
PROCEDURE
Magnetic Resonance Imaging (MRI)
Patients will have MRI scans every 6 months.
Primary outcome measures
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
Time frame: 5 years
We will test whether an abbreviated MRI (AB-MRI) is diagnostically equivalent to a full MRI. Eligible women will be scanned every 6 months with a full protocol MRI.
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
- \- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS. OR
- With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
- 5-years risk ≥ 6% for women 40-64 OR
- 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
- Patients with history of chest wall radiation received before age 35. OR
- To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
- Must be at least 25 years old.
- Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
- Be able to give informed consent.
- Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years.
Exclusion criteria
- Undergoing active cancer treatment at the time of enrollment.
- Current pregnancy or plans for pregnancy within two years of enrollment.
- Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
- Breast surgery within two weeks of study entry.
- Women with history of bilateral mastectomy are not eligible
- History of kidney disease or abnormal kidney function.
- History of dye allergy unless it can be mediated with antihistamines and/or steroids
- Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
Where
- Chicago, Illinois
Collaborators
National Cancer Institute (NCI)
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 Apr 27, 2026 · Source of record for eligibility and locations