Evaluating genetic risk for breast cancer in African American and Hispanic women
Genetic Risk Estimation in Breast Cancer and Assessing Health Disparities
This study is testing if using a genetic risk score can help African American and Hispanic women make better choices about breast cancer screening and prevention.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05755269 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if adding a polygenic risk score (PRS) to standard breast cancer risk assessments can help African American and Hispanic women make more informed decisions regarding breast cancer screening and prevention. Participants will complete surveys and provide blood samples for PRS genotyping, with follow-up surveys conducted over a 10-year period. The study will assess whether the inclusion of genetic risk information influences adherence to screening recommendations and decisions about preventative therapies.
Who should consider this trial
Good fit: Ideal candidates are African American or Hispanic women aged 30 to 75 with specific breast cancer risk factors.
Not a fit: Patients with a calculated low risk for breast cancer or those with a prior history of invasive breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower minority women with personalized risk information, leading to better screening and prevention strategies for breast cancer.
How similar studies have performed: Other studies have shown promise in using genetic risk scores to enhance breast cancer risk assessments, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who self-identify as African American/Black or Hispanic/Latinx * Women \>= 30 years old and =\< 75 years old * Women with any of the following: * IBIS (Tyrer-Cuzik) score of \>= 5% for the 10 year risk OR * BCRAT (Gail Model) score of \> 3 % for the 5 year risk * History of biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia (with risk calculator assessment A and B) * History of biopsy proven lobular carcinoma in situ (with risk calculator assessment A and B) * Able to participate in all aspects of the study * Understand and signed the study informed consent Exclusion Criteria: * Women whose calculated risk for breast cancer falls below the threshold * Unable to give informed consent * Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers * Women who are pregnant or breastfeeding * Prior use of prevention drugs for longer than 6 months * Prior risk reducing or prophylactic mastectomy * Known pathogenic genetic mutation linked to breast cancer (such as BRCA 1/2, PALB2, ATM, CHEK2)
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sabrina Sahni, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.