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

NCT07734389 | Recruiting

• 1 other identifier: ORI2025-2
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, up to 34 months

Secondary Outcomes (1)

• Agreement Between S-IBIS and CanRisk Breast Cancer Risk Classifications

  Through study completion, up to 34 months

Study Arms (1)

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.

Other: Comprehensive Clinical and Genetic Breast Cancer Risk Assessment

Interventions

Comprehensive Clinical and Genetic Breast Cancer Risk Assessment OTHER

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.

Comprehensive Breast Cancer Risk Assessment

Eligibility Criteria

• Age: 53 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• Diagnosis of breast cancer.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Clinical Cancer Genetics Clinic

CONTACT

+386 1 587 9649; genetika@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 29, 2026
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)