A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging (MRI).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chicago Alternative Prevention Study for Diverse Populations of High Risk Women
Overview
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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- University Of Chicago Medicine Comprehensive Cancer Center — Chicago
Identifiers
NCT: NCT03729115 · IRB18-0970 · 5R01CA276652