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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07734389
Lead Sponsor Institute of Oncology Ljubljana
Conditions Breast Cancer, Breast Cancer Risk
Enrollment 291 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov