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RECRUITING
NCT07734389
NA

Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme

Sponsor: Institute of Oncology Ljubljana

View on ClinicalTrials.gov

Summary

This prospective study evaluates whether a more detailed clinical and genetic assessment can improve the classification of individual breast cancer risk among women previously identified as having moderately increased or high breast cancer risk in the Slovenian DORA breast cancer screening programme. Women who agree to participate complete questionnaires and attend an individual genetic counseling appointment at the Institute of Oncology Ljubljana. Personal breast cancer risk factors are reviewed with the assistance of a specialist, and reported family cancer history is verified using data from the Slovenian Cancer Registry. Breast cancer risk is reassessed using the S-IBIS and CanRisk models. Genetic testing is offered to participants who meet the applicable clinical criteria. The study will evaluate changes in breast cancer risk classification, compare risk estimates obtained using the S-IBIS and CanRisk models, and provide participants with individualized recommendations for breast cancer screening and follow-up according to their reassessed risk.

Official title: Impact of Genetic Assessment on the Evaluation of Individual Breast Cancer Risk Among Women at Increased Risk in the DORA Programme

Key Details

Gender

FEMALE

Age Range

53 Years - 54 Years

Study Type

INTERVENTIONAL

Enrollment

291

Start Date

2025-03-10

Completion Date

2027-12-31

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

OTHER

Comprehensive Clinical and Genetic Breast Cancer Risk Assessment

Participants receive an individual clinical and genetic breast cancer risk assessment. Personal risk factors are reviewed with the assistance of a specialist, and family cancer history is verified using the Slovenian Cancer Registry. Breast cancer risk is calculated using the S-IBIS and CanRisk models. Genetic counseling is provided, and genetic testing is performed when the participant meets the applicable clinical criteria. Recommendations for screening and follow-up are adapted to the reassessed level of breast cancer risk.

Locations (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia