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Effect of Breast Implants om Mammography Screening

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05222100
Collaborator
(none)
2,500
Enrollment
1
Location
31.6
Anticipated Duration (Months)
79
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Mammography screening

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Breast Implants om Mammography Screening
Actual Study Start Date :
May 12, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Women without breast implants

Women without breast implants participating in the mammography screening program.

Diagnostic Test: Mammography screening
Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.
Other Names:
  • Mammogram screening
  • Breast screening
  • Screening mammogram
  • Screening mammography
  • Breast cancer screening

    		•
    Women with breast implants

    Women with breast implants participating in the mammography screening program.

    Diagnostic Test: Mammography screening
    Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.
    Other Names:
  • Mammogram screening
  • Breast screening
  • Screening mammogram
  • Screening mammography
  • Breast cancer screening

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Costs [1 year post-operatively]

      Health economic analysis of the effects of implants on mammography screening

    Secondary Outcome Measures

    1. Prevalence [1 year]

      Prevalence of breast implants in a mammography screening population.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • Women participating in the mammography screening program.
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska university hospital Gothenburg Sweden 413 45

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT05222100
    Other Study ID Numbers:
    • 2021-01534
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vastra Gotaland Region
    breast cancer
    plastic surgery
    breast implant
    mammography screening
    health economy
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Feb 3, 2022