Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age53-54
SponsorInstitute of Oncology Ljubljana
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Diagnosis of breast cancer.
Trial design
Design model
Single group
Treatments tested in this trial
Comprehensive Clinical and Genetic Breast Cancer Risk Assessment
Other interventionParticipants 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.
Treatment groups
291 Participants
are divided into 1 treatment groupGroup A: Comprehensive Breast Cancer Risk AssessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Reclassified to Population-Level Breast Cancer Risk
The number of participants previously classified as having moderately increased or high breast cancer risk who are reclassified as having population-level risk after the comprehensive reassessment will be divided by the total number of participants who complete the reassessment and expressed as a percentage. The comprehensive reassessment includes specialist-assisted review of personal breast cancer risk factors, verification of family cancer history, breast cancer risk calculation using the S-IBIS and CanRisk models, and genetic test results when available.
Time frame
Through study completion, up to 34 monthsSecondary outcomes
1
Agreement Between S-IBIS and CanRisk Breast Cancer Risk Classifications
The number and percentage of participants assigned to the same breast cancer risk category by the S-IBIS and CanRisk models will be reported. The evaluated categories are population-level risk, moderately increased risk, and high risk. The same available participant data will be used for both risk calculations.
Time frame
Through study completion, up to 34 monthsSponsors and contacts
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Source ClinicalTrials.gov