RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Genetic Risk Estimation in Breast Cancer and Assessing Health Disparities

Quick Facts

Study Start:2023-03-14
Study Completion:2033-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05755269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women who self-identify as African American/Black or Hispanic/Latinx
  2. * Women \>= 30 years old and =\< 75 years old
  3. * Women with any of the following:
  4. * IBIS (Tyrer-Cuzik) score of \>= 5% for the 10 year risk OR
  5. * BCRAT (Gail Model) score of \> 3 % for the 5 year risk
  6. * History of biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia (with risk calculator assessment A and B)
  7. * History of biopsy proven lobular carcinoma in situ (with risk calculator assessment A and B)
  8. * Able to participate in all aspects of the study
  9. * Understand and signed the study informed consent
  1. * Women whose calculated risk for breast cancer falls below the threshold
  2. * Unable to give informed consent
  3. * Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
  4. * Women who are pregnant or breastfeeding
  5. * Prior use of prevention drugs for longer than 6 months
  6. * Prior risk reducing or prophylactic mastectomy
  7. * Known pathogenic genetic mutation linked to breast cancer (such as BRCA 1/2, PALB2, ATM, CHEK2)

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Sabrina Sahni, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Sabrina Sahni, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2033-01-15

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2033-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Atypical Ductal Hyperplasia
  • Breast Atypical Lobular Hyperplasia
  • Breast Carcinoma
  • Breast Lobular Carcinoma In Situ