The Swedish Two-County Trial of Mammography Screening (WE)
Primary Purpose
Breast Neoplasm Female
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Imaging
Sponsored by
About this trial
This is an interventional screening trial for Breast Neoplasm Female
Eligibility Criteria
Inclusion criteria
- Female
- Aged 40-74
- No history of breast cancer
Exclusion criteria
• Breast cancer diagnosis prior to randomization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active Study Population
Passive Study Population
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Breast cancer death
Comparison of breast cancer mortality in the ASP versus PSP
Secondary Outcome Measures
Full Information
NCT ID
NCT03217539
First Posted
July 11, 2017
Last Updated
February 5, 2018
Sponsor
Dalarna County Council, Sweden
Collaborators
Ostergotland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03217539
Brief Title
The Swedish Two-County Trial of Mammography Screening
Acronym
WE
Official Title
The Two-County Swedish Mammography Screening Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 7, 1977 (Actual)
Primary Completion Date
September 9, 1986 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalarna County Council, Sweden
Collaborators
Ostergotland County Council, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The Swedish Two-county study is a randomized controlled trial of invitation to mammography screening. The trial took place in Kopparberg (W), now called Dalarna, and Ostergotland counties in Sweden. The trial randomized 77,080 women aged 40-74 years to invitation to screening (active study population, ASP) and 55,985 women to no invitation to screening (passive study population, PSP). The trial started in 1977 in W-county and in 1978 in E-county. Women in age 40-49 years were invited to single-view mammography screening on average every 24 months, and women aged 50-74 years on average every 33 months. Approximately seven years after randomization a significant 31% decrease in breast cancer mortality was observed in the ASP group, whereupon the PSP was invited to screening once and the screening phase of the trial ended. The mortality data have been reported every two years during the follow-up period and published in peer-reviewed medical journals. The investigators have follow-up data to the Dec 31 2015. The 29-year follow-up data has been published in 2012 in Radiology. Publication of the long-term data reflects the fact that deaths avoided by early detection include some that would have occurred a considerable time later than the screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133065 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Study Population
Arm Type
Experimental
Arm Description
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)
Arm Title
Passive Study Population
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Imaging
Other Intervention Name(s)
Screening mammography
Primary Outcome Measure Information:
Title
Breast cancer death
Description
Comparison of breast cancer mortality in the ASP versus PSP
Time Frame
9 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-representation
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Female
Aged 40-74
No history of breast cancer
Exclusion criteria
• Breast cancer diagnosis prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laszlo K Tabar, MD
Organizational Affiliation
Department of Mammography, Falun Central Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Swedish Two-County Trial of Mammography Screening
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