Breast Cancer ScreeningNCT07837245
Pilot Study of the Expansion of the DORA Breast Cancer Screening Programme
A study testing Screening Mammography in people with Breast Cancer Screening, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Screening Mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,150 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2025to Dec 2026
- 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 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex
- Age 45-49 years or 70-74 years
- Permanent or temporary residence in one of the following municipalities in the Ljubljana regional unit of the Health Insurance Institute of Slovenia: Ljubljana, Grosuplje, Ivančna Gorica, Dobrepolje, Škofljica, Ig, or Medvode
- Selected through random sampling from the Central Population Register and invited to participate in the study
- Written informed consent to participate.
Who cannot join
- No valid compulsory health insurance status or no valid Slovenian health insurance card
- Previous diagnosis of invasive or non-invasive breast cancer and registration in the Slovenian Cancer Registry
- For women aged 70-74 years: less than 2 years since the previous mammography within the DORA programme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study of the Expansion of the DORA Breast Cancer Screening Programme to Women Aged 45-49 and 70-74 Years
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.
Read the detailed description
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.
- Conditions
- Breast Cancer Screening
- Being tested
- Screening Mammography
- Keywords
- Breast cancer screening, Mammography, DORA screening programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening MammographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening Mammography | Experimental | 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. Receives: Diagnostic Test: Screening Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Participation Rate
Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Measured: 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.
Measured: At screening mammography, approximately 3-4 weeks after invitation
Secondary outcomes (1)
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.
Measured: 1 to 2 days after screening mammography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies 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
- Single-cohort study of women aged 45-49 and 70-74 years invited to screening mammography within the DORA programme.
- Masking
- None (open label)
- Enrolment
- 2,150 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
- NCT07837245
- Sponsor's protocol ID
- ORI2025-22
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Expansion of the DORA Breast Cancer Screening Programme to Women Aged 45-49 and 70-74 Years
- ClinicalTrials.gov ID
- NCT07837245
- Acronym / sponsor ID
- ORI2025-22
- Conditions
- Breast Cancer Screening
- Keywords
- Breast cancer screening, Mammography, DORA screening programme
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,150 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 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 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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-cohort study of women aged 45-49 and 70-74 years invited to screening mammography within the DORA programme.
| Arm | Type | Receives |
|---|---|---|
| Screening Mammography | Experimental | Diagnostic Test: Screening MammographyWomen 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. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female sex
- Age 45-49 years or 70-74 years
- Permanent or temporary residence in one of the following municipalities in the Ljubljana regional unit of the Health Insurance Institute of Slovenia: Ljubljana, Grosuplje, Ivančna Gorica, Dobrepolje, Škofljica, Ig, or Medvode
- Selected through random sampling from the Central Population Register and invited to participate in the study
- Written informed consent to participate.
Key exclusion criteria (3 listed)
- No valid compulsory health insurance status or no valid Slovenian health insurance card
- Previous diagnosis of invasive or non-invasive breast cancer and registration in the Slovenian Cancer Registry
- For women aged 70-74 years: less than 2 years since the previous mammography within the DORA programme.
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 |
|---|---|---|
| Screening MammographyParticipants 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. | Diagnostic test | Screening Mammography |
Primary outcome
Screening Participation Rate
Time frame: From invitation to the scheduled screening mammography appointment, approximately 3-4 weeks
Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
Referral Rate for Additional Assessment
Time frame: At screening mammography, approximately 3-4 weeks after invitation
Percentage of screened women referred for additional diagnostic assessment after screening mammography, assessed separately for women aged 45-49 years and 70-74 years.
1 secondary outcome
Participant Satisfaction and Communication Needs
Time frame: 1 to 2 days after screening mammography
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 23 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Mammography in people with Breast Cancer Screening, 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 23 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Participation Rate (time frame: From invitation to the scheduled screening mammography appointment, approximately 3-4 weeks). The study lists 2 primary outcomes in all. 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 23 Sep 2026.