Clinical trial · Observational
Adding a Genetic Risk Evaluation to Standard Breast Cancer Risk Assessment for African American and Hispanic Women
Genetic Risk Estimation in Breast Cancer and Assessing Health Disparities
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Atypical Ductal Hyperplasia | Breast Atypical Ductal Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Breast Atypical Lobular Hyperplasia | Breast Atypical Lobular Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Lobular Carcinoma In Situ | Breast Lobular Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Genotyping | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (blood collection, genotyping, surveys)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Genotyping
- Other: Survey Administration
Primary outcomes (7)
- measure
- Whether the addition of an individual polygenic risk score (PRS) to the Breast Cancer Risk Assessment Tool (BCRAT) will improve intentions to adhere to recommended breast cancer screening strategies
- timeFrame
- Up to 10 years
- description
- Continuous variables will be summarized as mean (standard deviation) or median (range) and categorical variables will be reported as frequency (percentage).
- measure
- Whether the addition of an individual polygenic risk score (PRS) to the Tyrer-Cuzick (IBIS) score will improve intentions to adhere to recommended breast cancer screening strategies
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available