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Comprehensive Genetic Assessment, Risk and Education among Women at Intermediate or High Risk of Breast Cancer, CARE at Mammography Study

Trial Status: Active

This clinical trial gathers information on the prevalence of genetic mutations in women who are at intermediate or high risk of breast cancer and how that information may assist providers in improving screening and preventative options for patients receiving clinical care at Mayo Clinic. The information obtained from the genetic results may identify an underlying genetic predisposition to cancer by the patient. The information gained from this research may advance researchers' understanding of the prevalence of cancer genetic syndromes in women undergoing mammography and the ability to optimize the delivery of genetic testing to women undergoing routine cancer screening.

Inclusion Criteria

  • Women participating in Institutional Review Board (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 Contrast Enhanced Digital Mammogram (CEDM) pilot
  • Known genetic cancer syndrome with test results available for review in Mayo electronic medical records (EMR)
  • Known breast cancer
  • Unable to understand or sign informed consent

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Niloy Jewel Samadder
Phone: 480-342-6263

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in this intermediate/high risk population of women presenting for screening mammography.

SECONDARY OBJECTIVES:

I. To evaluate the update of genetic testing by intermediate/high risk patients at mammography.

II. To evaluate genetic literacy, decisional conflict and decisional latency amongst this population using focused surveys.

OUTLINE:

Patients receive pre-test genetic counseling via pre-recorded video per standard of care. After watching the pre-test counseling video, patients have the option to undergo genetic testing. Patients who agree to undergo genetic testing, undergo collection of blood and saliva samples for testing. Patients also complete a survey regarding experience with the genetic testing process and factors that influence patient decisions to undergo genetic testing after genetic testing and within 2-4 weeks after receipt of genetic results. Patients who forego genetic testing after watching the video, complete a survey regarding decisional conflict, latency, attitudes surrounding video pre-test counseling.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
Mayo Clinic in Arizona

Principal Investigator
Niloy Jewel Samadder

  • Primary ID 19-004343
  • Secondary IDs NCI-2021-02684
  • Clinicaltrials.gov ID NCT04002986