ClinicalTrials.gg
Status unknownNCT02480933SISYPHUSUpdated Nov 28, 2017

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

An interventional study of Bilateral mastectomy and Biopsy in Female Breast Cancer and Male Breast Cancer, sponsored by Centro Hospitalar Lisboa Ocidental. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Centro Hospitalar Lisboa Ocidental · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
768
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Female Breast Cancer
  • Male Breast Cancer
03

In context

Breast Neoplasms, Male

286 studies on the registry are indexed under Breast Neoplasms, Male; 5 are open to participants now.

This study's planned enrollment of 768 is above the median of 37 across 230 interventional studies indexed under Breast Neoplasms, Male.

Browse Breast Neoplasms, Male studies →

Lead sponsor

Centro Hospitalar Lisboa Ocidental is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female and male cadavers above 40 years

Exclusion criteria

Exclusion Criteria:

  • Known breast cancer
  • Breast tissue accidental damage
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
768 participants (estimated)

Study arms

  • Experimental
    female cadavers

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

    Procedure: Bilateral mastectomy · Other: Biopsy

  • Experimental
    Male cadavers

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

    Procedure: Bilateral mastectomy · Other: Biopsy

Interventions

  • ProcedureBilateral mastectomy

    Bilateral mastectomy and imaging study of cadaveric breasts

  • OtherBiopsy

    Biopsy of BI-RADS 3 and superior lesions

06

What researchers measure

Primary outcomes

  1. Silent breast cancer prevalence

    To define the existing disease that did not caused death in both sexes

    Time frame: 2 years

Secondary outcomes

  1. Silent breast cancer prevalent molecular profile

    To identify those molecular subgroups of the disease that remain silent

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02480933
Lead sponsor
Centro Hospitalar Lisboa Ocidental
Collaborators
Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
Responsible party
Zacharoula Sidiropoulou (Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent, Centro Hospitalar Lisboa Ocidental) — Principal investigator
First posted
Jun 25, 2015
Start date
Sep 2016
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Nov 28, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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