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

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ClinicalTrials.gov Identifier: NCT02480933
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
Information provided by (Responsible Party):
Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental

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.

Condition or disease Intervention/treatment Phase
Female Breast Cancer Male Breast Cancer Procedure: Bilateral mastectomy Other: Biopsy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 768 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: female cadavers
female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
Procedure: Bilateral mastectomy
Bilateral mastectomy and imaging study of cadaveric breasts

Other: Biopsy
Biopsy of BI-RADS 3 and superior lesions

Experimental: Male cadavers
male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
Procedure: Bilateral mastectomy
Bilateral mastectomy and imaging study of cadaveric breasts

Other: Biopsy
Biopsy of BI-RADS 3 and superior lesions




Primary Outcome Measures :
  1. Silent breast cancer prevalence [ Time Frame: 2 years ]
    To define the existing disease that did not caused death in both sexes


Secondary Outcome Measures :
  1. Silent breast cancer prevalent molecular profile [ Time Frame: 2 years ]
    To identify those molecular subgroups of the disease that remain silent



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male cadavers above 40 years

Exclusion Criteria:

  • Known breast cancer
  • Breast tissue accidental damage

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: https://doi.org/10.3892/mco.20
feasibility of the protocol paper

Responsible Party: Zacharoula Sidiropoulou, Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent, Centro Hospitalar Lisboa Ocidental
ClinicalTrials.gov Identifier: NCT02480933     History of Changes
Other Study ID Numbers: CentroHLO
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases