Genetic Risk Estimation in Breast Cancer and Assessing Health Disparities

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Observational
SUMMARY

This study evaluates whether adding a polygenic risk score evaluation to standard breast cancer risk assessment tools helps African American and Hispanic women make more informed decisions about accepting additional breast cancer screening and prevention strategies. Traditional breast cancer risk assessments rely mostly on the presence of standard clinical risk factors including family history, reproductive history, and mammographic breast density. This information can be combined with validated risk estimation models to provide a measure of a patient's 10 year and lifetime risk for breast cancer. A polygenic risk score helps to estimate breast cancer risk in a more individualized way by evaluating a patient's genetics. Adding a polygenic risk score evaluation to traditional screening techniques may help minority women make more informed decisions about screening and prevention strategies for breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2033-01-15
Participants
Target number of participants: 50
Treatments
Observational (blood collection, genotyping, surveys)
Patients complete a survey and undergo collection of a blood sample for PRS genotyping at baseline. Patients receive their PRS results and complete another survey 6 weeks to 6 months after baseline and then complete surveys annually over 10 years on study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov