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Clinical Trials/NCT04002986
NCT04002986
Completed
Not Applicable

Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Mayo Clinic1 site in 1 country116 target enrollmentAugust 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
Sponsor
Mayo Clinic
Enrollment
116
Locations
1
Primary Endpoint
Genetic mutations
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 20, 2019
End Date
May 24, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Niloy Jewel (Jewel) Samadder

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Genetic mutations

Time Frame: One year

Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)

Study Participants

Time Frame: One year

Number of subjects who decide to undergo genetic panel testing

Study Sites (1)

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