Clinical trial · Observational
PERsonalized Mammographic Screening in Norway
PERsonalized Mammographic Screening in Norway; Additional Examination for Women With Increased Risk of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mammographic Breast Density | — | UNRESOLVED | — |
| Risk Stratification | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Women attending mammographic screening at three sites in BreastScreen Norway
- description
- 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)
Primary outcomes (2)
- measure
- Attendance rate to extra imaging with digital breast tomosynthesis for women with extremely high mammographic density
- timeFrame
- Women will be invited to the extra examination with DBT within 6 months after index screening mammography.
- description
- 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.
- measure
- Attendance rate to an additional screening mammography for women with false positive screening result
- timeFrame
- Women will be invited to the additional screening mammography within 12 months after index screening mammography.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 71 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available