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Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens (SISYPHUS)

Primary Purpose

Female Breast Cancer, Male Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral mastectomy
Biopsy
Sponsored by
Centro Hospitalar Lisboa Ocidental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Female Breast Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female and male cadavers above 40 years

Exclusion Criteria:

  • Known breast cancer
  • Breast tissue accidental damage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    female cadavers

    Male cadavers

    Arm Description

    female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy

    male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy

    Outcomes

    Primary Outcome Measures

    Silent breast cancer prevalence
    To define the existing disease that did not caused death in both sexes

    Secondary Outcome Measures

    Silent breast cancer prevalent molecular profile
    To identify those molecular subgroups of the disease that remain silent

    Full Information

    First Posted
    June 17, 2015
    Last Updated
    November 24, 2017
    Sponsor
    Centro Hospitalar Lisboa Ocidental
    Collaborators
    Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480933
    Brief Title
    Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
    Acronym
    SISYPHUS
    Official Title
    Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Hospitalar Lisboa Ocidental
    Collaborators
    Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to define silent breast cancer prevalence in both sexes and will be held by biopsies performed in imaging suspicious areas of the breast (ecography and mammography) in cadavers without known breast cancer.
    Detailed Description
    Cadavers of both sexes are going to be submitted to bilateral mastectomy. The specimens are going to be examined by palpation, ecography and mammography and all areas with (Breast Imaging Reporting and Data System) BI-RADS classification >= 3 are going to be biopsied. Biopsy specimens are going to be processed by the pathology department and cancers are going to be identified and classified by their molecular type. The investigators intend to know which is the disease reservoir in various ages.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Breast Cancer, Male Breast Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    768 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    female cadavers
    Arm Type
    Experimental
    Arm Description
    female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
    Arm Title
    Male cadavers
    Arm Type
    Experimental
    Arm Description
    male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral mastectomy
    Intervention Description
    Bilateral mastectomy and imaging study of cadaveric breasts
    Intervention Type
    Other
    Intervention Name(s)
    Biopsy
    Intervention Description
    Biopsy of BI-RADS 3 and superior lesions
    Primary Outcome Measure Information:
    Title
    Silent breast cancer prevalence
    Description
    To define the existing disease that did not caused death in both sexes
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Silent breast cancer prevalent molecular profile
    Description
    To identify those molecular subgroups of the disease that remain silent
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female and male cadavers above 40 years Exclusion Criteria: Known breast cancer Breast tissue accidental damage

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://www.spandidos-publications.com/mco
    Available IPD/Information Identifier
    https://doi.org/10.3892/mco.20
    Available IPD/Information Comments
    feasibility of the protocol paper

    Learn more about this trial

    Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens

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