PERsonalized Mammographic Screening in Norway

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-71
SponsorNorwegian Institute of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

invited to screening

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

Disqualifiers

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

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 1 trial group
Group A: Women attending mammographic screening at three sites in BreastScreen Norway

Trial outcomes

Primary outcomes

1

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.

Time frame
Women will be invited to the extra examination with DBT within 6 months after index screening mammography.
2

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian Institute of Public Health

Lead sponsor

Norwegian Cancer Society

Collaborator

University Hospital, Akershus

Collaborator

Oslo University Hospital

Collaborator

Vestre Viken Hospital Trust

Collaborator

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