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OpenTrials
Completed

NCT Number: NCT04002986

Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

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.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic Testing

Genetic

A blood draw or saliva kit will be provided to collect subject cells

Primary outcomes

  1. Genetic mutations

    Time frame: One year

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

  2. Study Participants

    Time frame: One year

    Number of subjects who decide to undergo genetic panel testing

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2019
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.