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Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer
NCT07076147 · University of Southern California
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
PRIMARY OBJECTIVE:
I. Among women without a history of breast cancer: to compare women with moderate risk breast cancer gene mutations (Mutation Carrier Group) to women with a 20-40% empiric lifetime risk of breast cancer (Empiric Risk Group) in terms of how likely they are to undergo recommended breast MRI screening.
OUTLINE: This is an observational study.
Patients complete a questionnaire and have their medical records reviewed on study.
Eligibility criteria
Inclusion Criteria:
* \* \>= 30 years
* =\< 75 years
* Women with either:
* Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (Mutation carrier group) OR
* Calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric risk group)
* Patients provided breast cancer risk assessments by genetic counselors at USC Norris or LA General Hospital beginning in 2021 and at least 12 months ago
* Women recommended to undergo annual breast MRI and/or annual mammogram beginning at the time of their genetic counseling risk assessment
* English or Spanish speaking patients
Exclusion Criteria:
* \* History of breast cancer before genetic counseling at University of Southern California (USC)
* Any metastatic cancer diagnosis at time of genetic counseling risk assessment
* Deceased
* Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment
Study design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-06-02
Estimated completion: 2028-06-02
Last updated: 2025-12-10
Interventions
Other: Non-Interventional Study
Primary outcomes
- • Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling (Up to 2 years)
Sponsor
University of Southern California · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorJacob Comeaux · principal_investigator, University of Southern California
All locations (2)
Los Angeles General Medical CenterRecruiting
Los Angeles, California, United States
USC / Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States