Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme

July 27, 2026 updated by: Institute of Oncology Ljubljana

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

291

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Cancer Genetics Clinic
  • Phone Number: +386 1 587 9649
  • Email: genetika@onko-i.si

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Institute of Oncology Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive Breast Cancer Risk Assessment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between S-IBIS and CanRisk Breast Cancer Risk Classifications
Time Frame: Through study completion, up to 34 months
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.
Through study completion, up to 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORI2025-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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