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.
Additional locations may be listed on ClinicalTrials.gov for NCT04002986.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 PhaseNo phase specified
Trial Typescreening
Lead OrganizationMayo Clinic in Arizona
Principal InvestigatorNiloy Jewel Samadder
