Genetic Risk Estimation and Improving Health Disparities in Breast Cancer Screening of Racial Minorities
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-003513
NCT ID: NCT05755269
Sponsor Protocol Number: MC220303
About this study
The aim of this study is to use the combine clinical risk assessment models that are already used in routine clinical practice with information derived from polygenic risk score (PRS) testing in women of racial minorities to see if this can improve adherence to recommended breast cancer screening and prevention strategies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women who identify as Black or Hispanic.
- Women > 30 years old and < 75 years old.
- Women with any of the following:
- IBIS (Tyrer-Cuzick) score for the lifetime risk ≥ 20%;
- History of biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia;
- History of biopsy proven lobular carcinoma in situ.
- Able to participate in all aspects of the study.
- Understand and signed the study informed consent.
Exclusion Criteria:
- Women whose lifetime risk for breast cancer falls below the threshold (< 20 % lifetime risk).
- Unable to give informed consent.
- Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers.
- At high risk due to prior radiation therapy to the chest.
- Women who are pregnant or breastfeeding.
- Prior risk reducing or prophylactic mastectomy.
Eligibility last updated 4/7/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Sabrina Sahni, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available