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Not yet recruiting NCT07371702

PERsonalized Mammographic Screening in Norway

Observational Breast Cancer Mammographic Breast Density Risk Stratification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Mammographic Breast Density, Risk Stratification. Basic parameters: 50 years — 71 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07371702 · 585149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗