PERsonalized Mammographic Screening in Norway

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07371702

Acronym

PERMS

Enrollment

3000

Registered

2026-01-28

Start date

2026-01-01

Completion date

2033-12-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Mammographic Breast Density, Risk Stratification

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 71 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

CONTACTSolveig Hofvind, PhD, professor

sshh@fhi.no+47 406 45 346

Outcome results