NCT03217539

Brief Summary

Population-based randomized controlled trial carried out in two Swedish counties, Dalarna and Ostergotland to find out the impact of early detection on mortality from breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
133,065

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 1977

Longer than P75 for not_applicable

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

July 7, 1977

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 1986

Completed
29.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

9.2 years

First QC Date

July 11, 2017

Last Update Submit

February 5, 2018

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

  • Breast cancer death

    Comparison of breast cancer mortality in the ASP versus PSP

    9 years

Study Arms (2)

Active Study Population

EXPERIMENTAL

In the experimental arm, women aged 40-74 who were randomly selected to receive an invitation to undergo imaging with periodic single view mammography screening. This arm is referred to as the Active Study Population (ASP)

Diagnostic Test: Imaging

Passive Study Population

NO INTERVENTION

In the no intervention arm, women aged 40-74 who were randomly selected to not receive an invitation to undergo periodic single view mammography screening received usual care. This arm is referred to as the Passive Study Population (PSP)

Interventions

ImagingDIAGNOSTIC_TEST
Also known as: Screening mammography
Active Study Population

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Aged 40-74
  • No history of breast cancer

You may not qualify if:

  • Breast cancer diagnosis prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Laszlo K Tabar, MD

    Department of Mammography, Falun Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus Professor

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 14, 2017

Study Start

July 7, 1977

Primary Completion

September 9, 1986

Study Completion

December 31, 2015

Last Updated

February 7, 2018

Record last verified: 2018-02