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Breast Cancer Screening for Women at Moderate Risk

This study is looking at how often women at a moderately increased risk for breast cancer get recommended breast MRI screenings. You might be eligible if you are a woman between 30 and 75 years old and have specific genetic test results (like a change in your ATM gene) or a calculated lifetime breast cancer risk between 20% and 40%. The study wants to understand what helps or hinders women from getting these screenings. Researchers will compare women with genetic mutations to those with a calculated risk to see if there are differences in screening rates. The main goal is to see what percentage of women get a screening breast MRI within 12 months of genetic test counseling.

Study design
This is an observational study with a planned enrollment of 150 women. It compares two groups of women at moderate risk for breast cancer.
What's involved
You would complete a questionnaire and have your medical records reviewed as part of this study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 2 years after genetic test counseling.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07076147

Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer

Recruiting
Not specifiedAges 30–75Observational
University of Southern California
~150 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling
Measured over Up to 2 years

Conditions

Breast Carcinoma

Explore related trials

Breast CarcinomaATM GeneBARD1 GeneRAD51C GeneRAD51D GeneSerine/Threonine-Protein Kinase Chk2

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Jacob Comeaux · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Jacob Comeaux
[email protected]
323-865-0474
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\* \>= 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

\* 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

What this trial measures

  • Proportion of women who undergo a screening breast MRI within 12 months of genetic test counselingUp to 2 years

    Will be calculated for each of the 4 Hospital-by-Age subgroups for the 2 risk groups; then a one-sided, α=0.05 Mantel Haenszel test, stratifying by hospital and age, will be used to compare the Mutation Carrier Risk and the Empiric Risk groups in terms of adherence to screening MRI. Homogeneity of odds ratios will be tested to ensure that difference (odds ratio) between the two risk groups is fairly consistent across the 4 strata.