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Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04002986
Recruitment Status : Enrolling by invitation
First Posted : July 1, 2019
Last Update Posted : February 27, 2020
Information provided by (Responsible Party):
Niloy Jewel (Jewel) Samadder, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8 Genetic: Genetic Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04002986

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: N. Jewel Samadder, MD Mayo Clinic
Additional Information:
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Responsible Party: Niloy Jewel (Jewel) Samadder, Principal Investigator, Mayo Clinic Identifier: NCT04002986    
Other Study ID Numbers: 19-004343
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Niloy Jewel (Jewel) Samadder, Mayo Clinic:
increased risk of breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases