Status:
NOT_YET_RECRUITING
Implementing Polygenic Risk Scores for Breast Cancer Prevention: a Feasibility Study
Lead Sponsor:
Boccia Stefania
Collaborating Sponsors:
Catholic University of the Sacred Heart
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this single-arm interventional study is to learn whether integrating a polygenic risk score (PRS) into the CanRisk model can help improve breast cancer risk prediction and prevention in ad...
Detailed Description
This single-arm feasibility study will integrate polygenic risk scores (PRS) into the CanRisk breast cancer risk model and evaluate the logistical and organizational aspects of its use in an establish...
Eligibility Criteria
Inclusion
- Ability to provide informed consent
- Voluntary consent to participate
- CanRisk score (without PRS) \> 5% (calculated on www.canrisk.org)
- Healthy women with:
- Known family history of breast cancer, or
- Known family history of genetic conditions associated with increased breast cancer risk, or
- Known carriers of pathogenic variants (BRCA1, BRCA2, PALB2, CHEK2, ATM, PTEN, TP53, CDH1)
- Affected women with:
- Diagnosis of unilateral breast cancer
- Personal history of ovarian cancer
Exclusion
- CanRisk score (without PRS) \< 5% (calculated on www.canrisk.org)
- Diagnosis or history of bilateral breast cancer
- Previous bilateral mastectomy
- Life expectancy \< 12 months due to other medical conditions
- Participation in interventional clinical trials for breast cancer prevention in the last 12 months
- Inability to provide informed consent
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06922708
Start Date
June 9 2025
End Date
May 30 2026
Last Update
June 3 2025
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