Breast Neoplasm FemaleWENCT03217539
The Swedish Two-County Trial of Mammography Screening
A study testing Imaging in people with Breast Neoplasm Female, run by Dalarna County Council, Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133,065 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 1977to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged 40-74
- No history of breast cancer
Who cannot join
- Breast cancer diagnosis prior to randomization
About this study
Official title: The Two-County Swedish Mammography Screening Trial
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.
Read the 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.
- Conditions
- Breast Neoplasm Female
- Being tested
- Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Also called Screening mammography
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer death
Comparison of breast cancer mortality in the ASP versus PSP
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start7 Jul 1977
- Primary completion9 Sep 1986
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Laszlo Tabar, MD, FACR (Hon), Dalarna County Council, Sweden
- Investigators
- Laszlo K Tabar, MD, Principal investigator, Department of Mammography, Falun Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217539
- Sponsor's protocol ID
- DalarnaCC
- Acronym
- WE
- Status last verified
- Feb 2018
- First submitted
- 11 Jul 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Two-County Swedish Mammography Screening Trial
- ClinicalTrials.gov ID
- NCT03217539
- Acronym / sponsor ID
- WE / DalarnaCC
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133,065 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Collaborators
- Ostergotland County Council, Sweden
- Study start
- 7 Jul 1977 (actual)
- Primary completion
- 9 Sep 1986 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Study Population | Experimental | Diagnostic Test: ImagingIn 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) |
| 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) |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Aged 40-74
- No history of breast cancer
Key exclusion criteria (1 listed)
- Breast cancer diagnosis prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingAlso: Screening mammography | Diagnostic test | Active Study Population |
Primary outcome
Breast cancer death
Time frame: 9 years
Comparison of breast cancer mortality in the ASP versus PSP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laszlo K Tabar, MD principal investigator
Department of Mammography, Falun Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Imaging in people with Breast Neoplasm Female, run by Dalarna County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer death (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.