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NCT05222100 Clinical Trial

Effect of Breast Implants om Mammography Screening

Breast Cancer Clinical Trial

Official title:
Effect of Breast Implants om Mammography Screening

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05222100
Other study ID # 2021-01534
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 12, 2021
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source Vastra Gotaland Region
Contact Emma Hansson, MD,PhD
Phone +46313421000
Email emma.em.hansson@vgregion.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers
Gender Female
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Women participating in the mammography screening program. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Mammography screening
Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.

Locations
Country Name City State
Sweden Sahlgrenska university hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Costs Health economic analysis of the effects of implants on mammography screening 1 year post-operatively
Secondary Prevalence Prevalence of breast implants in a mammography screening population. 1 year
Secondary Frequency of need for additional examinations Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography. 1 year
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