PERsonalized Mammographic Screening in Norway

NCT07371702 — Not yet recruiting, 3000 participants, Norwegian Institute of Public Health

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PERsonalized Mammographic Screening in Norway; Additional Examination for Women With Increased Risk of Breast Cancer

Registry	NCT07371702, acronym PERMS
Status	Not yet recruiting
Study type	Observational
Enrollment	3000 (Estimated)
Sponsor	Norwegian Institute of Public Health (Other gov); collaborators: Norwegian Cancer Society, University Hospital, Akershus, Oslo University Hospital, Vestre Viken Hospital Trust
Conditions	Breast Cancer, Mammographic Breast Density, Risk Stratification
Dates	start 2026-01-01 (estimated), primary completion 2028-01-01 (estimated), completion 2033-12-01 (estimated), first posted 2026-01-28, last updated 2026-01-29

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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)

+Outcome measures

Primary outcomes

Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density [Women will be invited to the extra examination with DBT within 6 months after index screening mammography.]: 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.
Attendance rate to an additional screening mammography for women with false positive screening result [Women will be invited to the additional screening mammography within 12 months after index screening mammography.]: 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.

+Eligibility

Sex: Female, ages: 50 Years to 71 Years, accepts healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

* 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