PERsonalized Mammographic Screening in Norway (PERMS)

January 27, 2026 updated by: Norwegian Institute of Public Health

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Solveig Hofvind, PhD, professor
  • Phone Number: +47 406 45 346
  • Email: sshh@fhi.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density
Time Frame: 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.
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
Time Frame: 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.
Women will be invited to the additional screening mammography within 12 months after index screening mammography.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

Vestre Viken Hospital Trust
Oslo University Hospital
University Hospital, Akershus
Norwegian Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 585149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared outside the project group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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