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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-02838 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determine if and how the availability of the PRS influenced patient decisions regarding preventive medicine and medication compliance. Because women know beforehand that the PRS is pending, study participants will be advised that a final decision to take preventive medicine must be deferred until after the PRS results are made available. Nevertheless, a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the PRS results and then another survey will be completed after receiving the PRS score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRS | Providing polygenic risk score (PRS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polygenic Risk Score | Genetic | A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 300 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (>40 %). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported intention to take a breast cancer preventing medication | up to 6 months after initial consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who are taking preventative medications each year for 10 years | Each year for up to 10 years | |
| Endocrine related quality of life scores each year for 10 years | Each year for up to 10 years |
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Inclusion Criteria:
Women >= 35 years old and =< 75 years old with at least one of the following:
Women >= 18 years old or =< 75 years old with a BRCA 1 or 2 mutation, CHEK 2, PALB 2, ATM, or other hereditary breast mutation carrier per investigator
Willing and able to provide an email address to receive study surveys
Able to participate in all aspects of the study
Understand and sign the study informed consent
Exclusion Criteria:
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Women attending the Mayo Clinic Breast Cancer clinics in Rochester, Arizona and Florida or the Mayo Clinic Health System in Austin or Albert Lea who meet eligibility criteria will be offered participation in this study after initial clinical calculation of the BCRAT or IBIS score and counseling as to the advisability of preventive therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Sandhya Pruthi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Participants indicate yes/no on consent form regarding retention of blood samples with DNA for future research.
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| Proportion of patient who are pursuing supplemental screening for 10 years | Each year for up to 10 years |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |