Back to resultsComprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Primary Purpose
Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic Testing
Sponsored by
About this trial
This is an interventional screening trial for Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8 focused on measuring increased risk of breast cancer
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
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Women at intermediate/high risk of breast cancer
Arm Description
Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing
Outcomes
Primary Outcome Measures
Genetic mutations
Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Study Participants
Number of subjects who decide to undergo genetic panel testing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04002986
Brief Title
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Official Title
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
Keywords
increased risk of breast cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women at intermediate/high risk of breast cancer
Arm Type
Experimental
Arm Description
Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing
Intervention Type
Genetic
Intervention Name(s)
Genetic Testing
Intervention Description
A blood draw or saliva kit will be provided to collect subject cells
Primary Outcome Measure Information:
Title
Genetic mutations
Description
Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Time Frame
One year
Title
Study Participants
Description
Number of subjects who decide to undergo genetic panel testing
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N. Jewel Samadder, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
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