Genetic assessment of breast cancer risk for women in the DORA programme
Official title: Impact of Genetic Assessment on the Evaluation of Individual Breast Cancer Risk Among Women at Increased Risk in the DORA Programme
Run by Institute of Oncology Ljubljana · NCT07734389 · Data updated 2026-11-12
This study tests whether a detailed clinical and genetic review can better classify breast cancer risk for women previously identified as moderately increased or high risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 53 Years to 54 Years |
| Sex | Women only |
| Enrollment | 291 (estimated) |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07734389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women who were identified as moderately increased or high risk in the prior DORA study and have not been diagnosed with breast cancer.
✕Probably not a fit
Participants without changes in risk classification or without recommended genetic testing may not experience direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women who previously enrolled in the Slovenian DORA screening programme and aged around 50 are invited for a deeper risk assessment. They complete questionnaires, have a genetic counseling session, and undergo verification of family cancer history with the Slovenian Cancer Registry. Risk is re-estimated using S-IBIS and CanRisk models, and genetic testing is offered if clinically indicated. The study compares updated risk classifications to prior assessments and provides individualized screening recommendations.
Why it matters
Potential benefit: If successful, participants may receive more accurate risk stratification and personalized screening guidance.
How similar studies have gone: Precedent exists for risk-model-based refinement in breast cancer screening, with potential for improved risk stratification, though this exact approach is part of a continuation within the DORA programme.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Institute of Oncology Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Study coordinator: Clinical Cancer Genetics Clinic
- Email: genetika@onko-i.si
- Phone: +386 1 587 9649
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.