An interventional study of Screening Mammography in Breast Cancer Screening, sponsored by Institute of Oncology Ljubljana. Enrolling by invitation at 1 site in Slovenia. Open to female participants aged 45 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Screening
This prospective interventional clinical study evaluates the feasibility of expanding the Slovenian national breast cancer screening programme DORA to women aged 45-49 years and 70-74 years. Women from selected municipalities will be invited to screening mammography. The study will assess participation rates, the proportion of women referred for additional diagnostic assessment, and other indicators relevant to planning the future expansion of the DORA programme.
The study is a prospective interventional cohort study conducted within the Slovenian national breast cancer screening programme DORA at the Institute of Oncology Ljubljana.
Women aged 45-49 years and 70-74 years will be selected from the Central Population Register and invited by mail to participate in screening mammography. Screening and any required additional diagnostic assessment will be performed according to the established procedures and quality standards of the DORA programme.
The primary objective is to evaluate key breast cancer screening quality indicators in the two age groups, including participation in screening and the proportion of screened women referred for additional assessment. The study will also collect information relevant to the development of age-specific communication strategies and to the planning of personnel, equipment, information systems, and infrastructure required for a possible expansion of the national screening programme to women aged 45-74 years.
The planned sample size is approximately 2,150 women.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 2,150 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institute of Oncology Ljubljana is the lead sponsor of 81 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women aged 45-49 years and 70-74 years will be invited to undergo screening mammography within the DORA breast cancer screening programme. Screening and any required additional assessment will follow the established DORA programme procedures.
Diagnostic Test: Screening Mammography
Participants will undergo breast cancer screening with mammography according to the established procedures of the Slovenian DORA screening programme. Women with findings requiring further evaluation will undergo additional diagnostic assessment according to the DORA protocol.
Screening Participation Rate
Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Time frame: From invitation to the scheduled screening mammography appointment, approximately 3-4 weeks
Referral Rate for Additional Assessment
Percentage of screened women referred for additional diagnostic assessment after screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Time frame: At screening mammography, approximately 3-4 weeks after invitation
Participant Satisfaction and Communication Needs
Participant-reported satisfaction with the screening process assessed using an anonymous SMS questionnaire. Items are rated on a 5-point scale from 1 (Very poor) to 5 (Excellent), with higher scores indicating greater satisfaction.
Time frame: 1 to 2 days after screening mammography
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 15 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Institute of Oncology Ljubljana