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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
Dalarna County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Neoplasm Female

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 11, 2017
    Last Updated
    February 5, 2018
    Sponsor
    Dalarna County Council, Sweden
    Collaborators
    Ostergotland County Council, Sweden
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    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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