Pilot Study of the Expansion of the DORA Breast Cancer Screening Programme

NCT07837245 | Enrolling By Invitation

• 1 other identifier: ORI2025-22
• Study Type: interventional
• Target: 2,150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Screening

Keywords

Breast cancer screening; Mammography; DORA screening programme

Outcome Measures

Primary Outcomes (2)

• Screening Participation Rate

  Percentage of invited women who undergo screening mammography, assessed separately for women aged 45-49 years and 70-74 years.

  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.

  At screening mammography, approximately 3-4 weeks after invitation

Secondary Outcomes (1)

• Participant Satisfaction and Communication Needs

  1 to 2 days after screening mammography

Study Arms (1)

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.

Diagnostic Test: Screening Mammography

Interventions

Screening Mammography DIAGNOSTIC_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.

Screening Mammography

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

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: Single-cohort study of women aged 45-49 and 70-74 years invited to screening mammography within the DORA programme.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)