Effect of Breast Implants om Mammography Screening

Recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Mammography screening

• Registration Number: NCT05222100
• Lead Sponsor: Vastra Gotaland Region

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-23
• Study First Posted: 2022-02-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

• Women participating in the mammography screening program.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women without breast implants	Mammography screening	Women without breast implants participating in the mammography screening program.
Women with breast implants	Mammography screening	Women with breast implants participating in the mammography screening program.

Primary Outcome Measures

Name	Time	Method
Costs	1 year post-operatively	Health economic analysis of the effects of implants on mammography screening

Secondary Outcome Measures

Name	Time	Method
Prevalence	1 year	Prevalence of breast implants in a mammography screening population.
Frequency of need for additional examinations	1 year	Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography.

Trial Locations

Locations (1)

Sahlgrenska university hospital; 🇸🇪 Gothenburg, Sweden