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

NCT ID: NCT02480933

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Female Breast Cancer Male Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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female cadavers

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

Group Type EXPERIMENTAL

Bilateral mastectomy

Intervention Type PROCEDURE

Bilateral mastectomy and imaging study of cadaveric breasts

Biopsy

Intervention Type OTHER

Biopsy of BI-RADS 3 and superior lesions

Male cadavers

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

Group Type EXPERIMENTAL

Bilateral mastectomy

Intervention Type PROCEDURE

Bilateral mastectomy and imaging study of cadaveric breasts

Biopsy

Intervention Type OTHER

Biopsy of BI-RADS 3 and superior lesions

Interventions

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Bilateral mastectomy

Bilateral mastectomy and imaging study of cadaveric breasts

Intervention Type PROCEDURE

Biopsy

Biopsy of BI-RADS 3 and superior lesions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male cadavers above 40 years

Exclusion Criteria

* Known breast cancer
* Breast tissue accidental damage
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar Lisboa Ocidental

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zacharoula Sidiropoulou

Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent

Responsibility Role PRINCIPAL_INVESTIGATOR

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CentroHLO

Identifier Type: -

Identifier Source: org_study_id