Breast CancerNCT05222100
Effect of Breast Implants om Mammography Screening
An observational study of Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography screening
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 12 May 2021to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Adult, Older adult
Study population: Women participating in the mammography screening program in Gothenburg, Sweden.
Who may be able to join
- Women participating in the mammography screening program.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 413 45
Emma Hansson, PhD, +46 31 342 10 00, emma.hansson.2@gu.se
About this study
The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.
- Conditions
- Breast Cancer
- Being tested
- Mammography screening
- Keywords
- breast cancer, plastic surgery, breast implant, mammography screening, health economy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography screeningDiagnostic test
Also called Mammogram screening, Breast screening, Screening mammogram, Screening mammography
Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.
| Study group | Role | What they receive |
|---|---|---|
| Women without breast implants | Women without breast implants participating in the mammography screening program. Receives: Diagnostic Test: Mammography screening | |
| Women with breast implants | Women with breast implants participating in the mammography screening program. Receives: Diagnostic Test: Mammography screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs
Health economic analysis of the effects of implants on mammography screening
Measured: 1 year post-operatively
Secondary outcomes (2)
Prevalence
Prevalence of breast implants in a mammography screening population.
Measured: 1 year
Frequency of need for additional examinations
Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start12 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222100
- Sponsor's protocol ID
- 2021-01534
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansson E, Zaya S, Meyer S, Freiin von Wrangel A, Warnberg F, Zackrisson S. Prevalence of women with breast implants in Sweden: a study based on the population-based mammography screening programme. J Plast Surg Hand Surg. 2023 Sep 20;58:96-100. doi: 10.2340/jphs.v58.15298.
PubMed 37728392
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breast Implants om Mammography Screening
- ClinicalTrials.gov ID
- NCT05222100
- Acronym / sponsor ID
- 2021-01534
- Conditions
- Breast Cancer
- Keywords
- breast cancer, plastic surgery, breast implant, mammography screening, health economy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2022 (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.
The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women without breast implants | – | Diagnostic Test: Mammography screeningWomen without breast implants participating in the mammography screening program. |
| Women with breast implants | – | Diagnostic Test: Mammography screeningWomen with breast implants participating in the mammography screening program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women participating in the mammography screening program in Gothenburg, Sweden.
Key inclusion criteria (1 listed)
- Women participating in the mammography screening program.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mammography screeningAlso: Mammogram screening, Breast screening, Screening mammogram, Screening mammographyBreast screening mammograms use X-rays to look for cancers that are too small to see or feel. | Diagnostic test | Women with breast implants, Women without breast implants |
Primary outcome
Costs
Time frame: 1 year post-operatively
Health economic analysis of the effects of implants on mammography screening
2 secondary outcomes
Prevalence
Time frame: 1 year
Frequency of need for additional examinations
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 37728392Hansson E, Zaya S, Meyer S, Freiin von Wrangel A, Warnberg F, Zackrisson S. Prevalence of women with breast implants in Sweden: a study based on the population-based mammography screening programme. J Plast Surg Hand Surg. 2023 Sep 20;58:96-100. doi: 10.2340/jphs.v58.15298.
- Research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Vastra Gotaland Region at 1 site in 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 1 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, MD,PhD (+46313421000, emma.em.hansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs (time frame: 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222100, which also lists 1 linked publication.
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 3 Jul 2025.