An interventional study of Comprehensive Clinical and Genetic Breast Cancer Risk Assessment in Breast Cancer and Breast Cancer Risk, sponsored by Institute of Oncology Ljubljana. Recruiting at 1 site in Slovenia. Open to female participants aged 53 Years to 54 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Screening
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.
This study is a continuation of a previous study conducted within the Slovenian DORA breast cancer screening programme. The previous study included women who turned 50 years of age in 2021, were invited for their first screening mammography in the DORA programme, completed a breast cancer risk questionnaire, and provided informed consent.
In the previous study, breast cancer risk was initially estimated using the S-IBIS model on the basis of questionnaire data and mammographic information. A total of 291 women were identified as having moderately increased or high breast cancer risk. Because the initial assessment was based mainly on self-reported information and did not include expert-assisted verification of all risk factors and family cancer history, these women are invited to participate in a more detailed risk assessment.
Participants who provide consent complete additional questionnaires and attend an individual consultation at the Department of Clinical Cancer Genetics of the Institute of Oncology Ljubljana. During the consultation, personal breast cancer risk factors and family cancer history are reviewed with a specialist. Reported cancer diagnoses in family members are verified, where possible, using the Slovenian Cancer Registry. Information collected includes personal characteristics, breast cancer risk factors, family history of cancer, breast tissue density, and genetic test results when genetic testing is performed.
Individual breast cancer risk is reassessed using the S-IBIS and CanRisk models. Genetic testing is offered when the participant meets the criteria defined in the applicable clinical guidelines. Following completion of the assessment, each participant receives recommendations for further breast cancer screening and follow-up according to her reassessed level of risk.
The study hypothesis is that more than half of the women initially classified as having increased breast cancer risk will be reclassified as having population-level risk after the detailed reassessment. The primary objective is to provide women who remain at moderately increased or high risk with more appropriate risk-adapted screening and follow-up. The secondary objective is to evaluate agreement between breast cancer risk estimates obtained using the S-IBIS and CanRisk models.
The study includes women previously classified as having moderately increased or high breast cancer risk. Women with a diagnosis of breast cancer are excluded. Data will be analyzed using descriptive statistical methods and will be processed in a pseudonymized form.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 291 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institute of Oncology Ljubljana is the lead sponsor of 81 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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.
Exclusion Criteria:
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.
Other: Comprehensive 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.
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 months
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 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institute of Oncology Ljubljana