NCT07734389 Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme
| NCT ID | NCT07734389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 291 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 291 participants in total. It began in 2025-03-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: \- 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: * Diagnosis of breast cancer.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07734389 clinical trial?
This trial is open to female participants only, aged 53 Years or older, up to 54 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07734389 currently recruiting?
Yes, NCT07734389 is actively recruiting participants. Contact the research team at genetika@onko-i.si for enrollment information.
Where is the NCT07734389 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07734389 clinical trial?
NCT07734389 is sponsored by Institute of Oncology Ljubljana. The trial plans to enroll 291 participants.
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