PERsonalized Mammographic Screening in Norway

NCT07371702 | Not Yet Recruiting

• 1 other identifier: 585149
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess attendance among women invited to additional breast imaging because they were identified as having an increased risk of breast cancer at screening. High-risk women were defined in two studies: Study A; women with high mammographic density, representing approximately 3-5% of screened women, and Study B; women with a false-positive screening result. Women in Study A will be offered an additional screening examination with digital breast tomosynthesis immediately within 6 months after the screening examination. Women in Study B will be offered an additional standard digital mammography examination one year after their initial screening.

Conditions

Breast Cancer; Mammographic Breast Density; Risk Stratification

Keywords

Breast Cancer Screening; personalized screening; breast cancer screening; personalized screening

Outcome Measures

Primary Outcomes (2)

• Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density

  Women with extremely dense breasts will be offered an extra examination with DBT within 6 months after index screening mammography. The investigators will assess the attendance rate to this extra examination.

  Women will be invited to the extra examination with DBT within 6 months after index screening mammography.

• Attendance rate to an additional screening mammography for women with false positive screening result

  Women with false positive screening result will be offered an additional screening mammography within 12 months after index screening mammography. The investigators will assess the attendance rate to this additional examination.

  Women will be invited to the additional screening mammography within 12 months after index screening mammography.

Study Arms (1)

Women attending mammographic screening at three sites in BreastScreen Norway

Those 3-5% with the highest mammographic density in Study A and those with a false positive screening result in Study B will be offered additional imaging with digital breast tomosynthesis within 6 months after the screening examination (A) and an additional standard screening examination after one year (B)

Eligibility Criteria

• Age: 50 Years - 71 Years
• Gender Eligibility Details: Only women are invited to mammographic screening
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study A will take place at the University Hospital of Akershus, while Study B will take place in Drammen, Vestre Viken Hospital and Oslo University Hospital

You may qualify if:

• invited to screening
• extremely dense breast (Study A) or a false positive screening result (Study B)

You may not qualify if:

• Opted out or not signed written consent related to the study
• Women who have opted out from giving us permission to use screening data for quality assurance and research

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Norwegian Cancer Society: collaborator
• University Hospital, Akershus: collaborator
• Oslo University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Solveig Hofvind, PhD, professor

CONTACT

+47 406 45 346; sshh@fhi.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: January 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share