Breast CancerNCT07734389
Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme
A study testing Comprehensive Clinical and Genetic Breast Cancer Risk Assessment in people with Breast Cancer and Breast Cancer Risk, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 53 to 54 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Risk
- What is being tested?
- Comprehensive Clinical and Genetic Breast Cancer Risk Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 53 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of breast cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Katja Jarm, MD, PhD, +38615879573, kjarm@onko-i.si
About this study
Official title: Impact of Genetic Assessment on the Evaluation of Individual Breast Cancer Risk Among Women at Increased Risk in the DORA Programme
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast Cancer Risk
- Being tested
- Comprehensive Clinical and Genetic Breast Cancer Risk Assessment
- Keywords
- Breast Cancer Risk Assessment, Breast Cancer Screening, Genetic Counseling, Genetic Testing, Risk-Adapted Screening, Family History of Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Clinical and Genetic Breast Cancer Risk AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Breast Cancer Risk Assessment | Experimental | 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. Receives: Other: Comprehensive Clinical and Genetic Breast Cancer Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 34 months
Secondary 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.
Measured: Through study completion, up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants undergo the same comprehensive breast cancer risk reassessment, including genetic counseling, evaluation using the S-IBIS and CanRisk models, verification of family cancer history, and genetic testing when clinically indicated. There is no comparator group.
- Masking
- None (open label)
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734389
- Sponsor's protocol ID
- ORI2025-2
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Genetic Assessment on the Evaluation of Individual Breast Cancer Risk Among Women at Increased Risk in the DORA Programme
- ClinicalTrials.gov ID
- NCT07734389
- Acronym / sponsor ID
- ORI2025-2
- Conditions
- Breast Cancer, Breast Cancer Risk
- Keywords
- Breast Cancer Risk Assessment, Breast Cancer Screening, Genetic Counseling, Genetic Testing, Risk-Adapted Screening, Family History of Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants undergo the same comprehensive breast cancer risk reassessment, including genetic counseling, evaluation using the S-IBIS and CanRisk models, verification of family cancer history, and genetic testing when clinically indicated. There is no comparator group.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Breast Cancer Risk Assessment | Experimental | Other: Comprehensive Clinical and Genetic Breast Cancer Risk AssessmentParticipants 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. |
Who may qualify
- Ages
- 53 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosis of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Clinical and Genetic Breast Cancer Risk AssessmentParticipants 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. | Other | Comprehensive Breast Cancer Risk Assessment |
Primary outcome
Proportion of Participants Reclassified to Population-Level Breast Cancer Risk
Time frame: Through study completion, up to 34 months
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.
1 secondary outcome
Agreement Between S-IBIS and CanRisk Breast Cancer Risk Classifications
Time frame: Through study completion, up to 34 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Clinical and Genetic Breast Cancer Risk Assessment in people with Breast Cancer and Breast Cancer Risk, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Cancer Genetics Clinic (+386 1 587 9649, genetika@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Reclassified to Population-Level Breast Cancer Risk (time frame: Through study completion, up to 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.