NCT03669926

Brief Summary

The aim of the study is to compare early performance measures and economic aspects of organized breast cancer screening for women screened using digital breast tomosynthesis+synthetic mammography (DBT+SM) to women with a prior DBT+SM or digital mammography (DM) from To-Be 1 (NCT02835625).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,082

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 28, 2024

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

September 3, 2018

Last Update Submit

August 26, 2024

Conditions

Breast Neoplasms

Keywords

Diagnostic ImagingMammographyTomosynthesisBreast cancer screeningSubsequent screeningCancer detectionCost effectivenessEarly performance measuresInterval cancer

Outcome Measures

Primary Outcomes (1)

  • Compare rates of screen detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program.

    Rate of screening detected breast cancer, among those screened

    48 months from start up of the trial

Secondary Outcomes (8)

  • Compare recall rates after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program.

    48 months from start up of the trial

  • Positive predictive value of recalls after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program.

    48 months from start up of the trial

  • Prognostic and predictive tumor characteristics for screening detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program.

    48 months from start up of the trial

  • Rate of interval breast cancer following screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program.

    48 months from start up of the trial

  • Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM.

    24-48 month after start up of the trial

  • +3 more secondary outcomes

Study Arms (1)

DBT+SM

OTHER

Digital Breast Tomosynthesis+synthetic mammography (DBT+SM) All women are screened with DBT+SM. All examinations are independently double read. Consensus used to decide whether or not to recall.

Radiation: Digital Breast Tomosynthesis+synthetic mammography

Interventions

Digital Breast Tomosynthesis+synthetic mammographyRADIATION

Two-view tomosynthesis performed with GE Senographe Pristina.

Also known as: DBT+SM
DBT+SM

Eligibility Criteria

Age48 Years - 71 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women are invited to breast cancer screening in BreastScreenn Norway.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written, informed consent to participation

You may not qualify if:

  • No written, informed consent to participation
  • Breast implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Registry of Norway

Oslo, 0379, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Solveig Hofvind, Professor

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 13, 2018

Study Start

January 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2023

Last Updated

August 28, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

We will not share the data outside the project group

Locations

NO(1)