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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 53
Maximum Age: 54
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Clinical Cancer Genetics Clinic
genetika@onko-i.si
+386 1 587 9649
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 291
Treatments
Experimental: Comprehensive Breast Cancer Risk Assessment
Participants undergo a comprehensive reassessment of individual breast cancer risk. The assessment includes specialist-assisted review of personal risk factors, verification of family cancer history, risk calculation using the S-IBIS and CanRisk models, genetic counseling, and genetic testing when clinically indicated. Participants receive risk-adapted recommendations for further breast cancer screening and follow-up.
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana

This content was sourced from clinicaltrials.gov