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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Breast Cancer Risk

In brief

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.

Key facts

Study ID

NCT07734389

Run by

Institute of Oncology Ljubljana

People needed

291

Starts

2025-03-10

Expected to finish

2027-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 53 and older, up to 54. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who participated in the previous DORA study and were classified by the S-IBIS model as having moderately increased or high breast cancer risk.

You may not qualify if…

• Diagnosis of breast cancer.

Where it is running

• Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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