MedTrace Logo

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

NCT07734389 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2026-07-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
53 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734389 on ClinicalTrials.gov