Adding a Genetic Risk Evaluation to Standard Breast Cancer Risk Assessment for African American and Hispanic Women

Trial Title: Adding a Genetic Risk Evaluation to Standard Breast Cancer Risk Assessment for African American and Hispanic Women

NCT ID: NCT05755269

Condition: Breast Atypical Ductal Hyperplasia
Breast Atypical Lobular Hyperplasia
Breast Carcinoma
Breast Lobular Carcinoma In Situ

Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Lobular
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Hyperplasia

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo collection of blood samples
Arm group label: Observational (blood collection, genotyping, surveys)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Genotyping
Description: Undergo genotyping
Arm group label: Observational (blood collection, genotyping, surveys)

Other name: GENOTYPE

Other name: Genotype Analysis

Other name: Genotype Assay

Intervention type: Other
Intervention name: Survey Administration
Description: Complete surveys
Arm group label: Observational (blood collection, genotyping, surveys)

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.

Detailed description: PRIMARY OBJECTIVES: I. To explore if the addition of an individual polygenic risk score (PRS) to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will improve intentions to adhere to recommended breast cancer screening strategies such as mammography, magnetic resonance imaging (MRI), or molecular breast Imaging in women of underserved racial minorities. II. To explore if the addition of the PRS to the BCRAT or IBIS risk score will aid women in deciding whether to take preventative endocrine therapy in women of racial minorities. III. To understand how individualized risk assessment and information on PRS may alter perceived risk of breast cancer. IV. To follow this cohort of women over 10 years to determine subsequent outcomes in regards to diagnoses of at-risk lesions or cancer. OUTLINE: This is an observational study. 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.

Criteria for eligibility:

Study pop:
African American/Black or Hispanic/Latinx women attending the Mayo Clinic Breast Center.

Sampling method: Non-Probability Sample
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)

Gender: Female

Minimum age: 30 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Florida

Address:
City: Jacksonville
Zip: 32224-9980
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Sabrina Sahni, M.D.
Email: Principal Investigator

Start date: March 14, 2023

Completion date: January 15, 2033

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05755269
https://www.mayo.edu/research/clinical-trials