Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

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

Official title:

Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002986
• Other study ID #: 19-004343
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: May 24, 2021

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 24, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Genetic:
• Genetic Testing
A blood draw or saliva kit will be provided to collect subject cells

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic mutations	Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)	One year
Primary	Study Participants	Number of subjects who decide to undergo genetic panel testing	One year

External Links

•   Mayo Clinic Clinical Trials