Recruiting

Breast Cancer Screening

Sponsor:

University of Southern California

Code:

NCT07076147

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.

Conditions

Breast Carcinoma

Study ID

NCT07076147

Start date

Jun 2, 2025

Status verified date

May, 2026

Completion date

Jun 2, 2028

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

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

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients complete a questionnaire and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jacob Comeaux

323-865-0474Jacob.Comeaux@med.usc.edu

Principal Investigator:

Jacob Comeaux

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jacob Comeaux

323-865-0474Jacob.Comeaux@med.usc.edu

Principal Investigator:

Jacob Comeaux

More Information

Sponsor

University of Southern California

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-01.