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

Male Breast Cancer Clinical Trial

— SISYPHUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02480933
• Other study ID #: CentroHLO
• Status: Active, not recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: November 24, 2017
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: November 2017
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 768
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Female and male cadavers above 40 years

Exclusion Criteria:

• Known breast cancer

• Breast tissue accidental damage

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Female Breast Cancer
• Male Breast Cancer

Intervention

Procedure:
• Bilateral mastectomy
Bilateral mastectomy and imaging study of cadaveric breasts

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental	Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silent breast cancer prevalence	To define the existing disease that did not caused death in both sexes	2 years
Secondary	Silent breast cancer prevalent molecular profile	To identify those molecular subgroups of the disease that remain silent	2 years