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

November 24, 2017 updated by: Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

768

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male cadavers above 40 years

Exclusion Criteria:

  • Known breast cancer
  • Breast tissue accidental damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silent breast cancer prevalence
Time Frame: 2 years
To define the existing disease that did not caused death in both sexes
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silent breast cancer prevalent molecular profile
Time Frame: 2 years
To identify those molecular subgroups of the disease that remain silent
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Lisboa Ocidental

Collaborators

Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CentroHLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: https://doi.org/10.3892/mco.20
    Information comments: feasibility of the protocol paper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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