Breast CancerPERMSNCT07371702
PERsonalized Mammographic Screening in Norway
An observational study of Breast Cancer and Mammographic Breast Density, run by Norwegian Institute of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 71 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mammographic Breast Density, Risk Stratification
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2033
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 71 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- invited to screening
- extremely dense breast (Study A) or a false positive screening result (Study B)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Keywords
- Breast Cancer Screening, personalized screening, breast cancer screening; personalized screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Women will be invited to the additional screening mammography within 12 months after index screening mammography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian Cancer Society, University Hospital, Akershus, Oslo University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371702
- Sponsor's protocol ID
- 585149
- Acronym
- PERMS
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared outside the project group
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERsonalized Mammographic Screening in Norway; Additional Examination for Women With Increased Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT07371702
- Acronym / sponsor ID
- PERMS / 585149
- Keywords
- Breast Cancer Screening, personalized screening, breast cancer screening; personalized screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian Cancer Society, University Hospital, Akershus, Oslo University Hospital, Vestre Viken Hospital Trust
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 50 to 71 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- invited to screening
- extremely dense breast (Study A) or a false positive screening result (Study B)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No. Data will not be shared outside the project group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Mammographic Breast Density, run by Norwegian Institute of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solveig Hofvind, PhD, professor (+47 406 45 346, sshh@fhi.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.