Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Mayo Clinic

Status: Completed

Conditions: Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8

Treatments: Genetic: Genetic Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04002986

19-004343

Details and patient eligibility

About

Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.

Enrollment: 116 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women participating in IRB:18-010601
• Aged 35 and over with a negative routine mammogram within 3 months.
• Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).
• Have an active email address for survey completion

Exclusion criteria

• Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
• Known genetic cancer syndrome with test results available for review in Mayo EMR
• Known breast cancer
• Unable to understand or sign informed consent

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Women at intermediate/high risk of breast cancer

Experimental group

Description:

Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing

Treatment:

Genetic: Genetic Testing