Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

July 20, 2023 updated by: Niloy Jewel (Jewel) Samadder, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women at intermediate/high risk of breast cancer
Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing
Genetic: Genetic Testing
A blood draw or saliva kit will be provided to collect subject cells

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: N. Jewel Samadder, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

May 24, 2021

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-004343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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