RecruitingNot ApplicableNCT07734389

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

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


Sponsor

Institute of Oncology Ljubljana

Enrollment

291 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 53 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Comprehensive Clinical and Genetic Breast Cancer Risk Assessment for people with breast cancer and breast cancer risk. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERComprehensive 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

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NCT07734389


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