Overview

This trial is active, not recruiting.

Conditions female breast cancer, male breast cancer
Treatments bilateral mastectomy, biopsy
Sponsor Centro Hospitalar Lisboa Ocidental
Collaborator Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
Start date September 2016
End date September 2017
Trial size 768 participants
Trial identifier NCT02480933, CentroHLO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose diagnostic
Arm
(Experimental)
female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
bilateral mastectomy
Bilateral mastectomy and imaging study of cadaveric breasts
biopsy
Biopsy of BI-RADS 3 and superior lesions
(Experimental)
male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
bilateral mastectomy
Bilateral mastectomy and imaging study of cadaveric breasts
biopsy
Biopsy of BI-RADS 3 and superior lesions

Primary Outcomes

Measure
Silent breast cancer prevalence
time frame: 2 years

Secondary Outcomes

Measure
Silent breast cancer prevalent molecular profile
time frame: 2 years

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Female and male cadavers above 40 years Exclusion Criteria: - Known breast cancer - Breast tissue accidental damage

Additional Information

Official title Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Centro Hospitalar Lisboa Ocidental.