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

ConditionBreast Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age30-75

SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

* >= 30 years

=< 75 years

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)

Disqualifiers

* 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

Trial population

Women provided with a breast cancer risk assessment by genetic counselors at USC Norris or LA General Hospital 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 or a calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model who are recommended to undergo annual breast MRI and/or annual mammogram.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Non-Interventional Study
Other intervention
Non-interventional study

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Observational1 intervention

Trial outcomes

Primary outcomes

Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling

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.

Time frame

Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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