Silent Breast Cancer A Study of the Disease Prevalence He... | NCT02480933

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

NCT02480933

Sponsor

Centro Hospitalar Lisboa Ocidental

Status

Unknown status

Last Update Posted

Nov 28, 2017Actual

Enrollment

768Estimated

Phase

Not Applicable

Conditions

Female Breast Cancer
Male Breast Cancer

Interventions

Bilateral mastectomy
Biopsy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jun 22, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2017

Last Update Posted Date

Nov 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zacharoula Sidiropoulou, Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent, Centro Hospitalar Lisboa OcidentalPrincipal Investigator

Lead Sponsor

Centro Hospitalar Lisboa OcidentalOTHER_GOV

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

768Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
female cadavers	Experimental	female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy	Procedure: Bilateral mastectomy Other: Biopsy
Male cadavers	Experimental	male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy	Procedure: Bilateral mastectomy Other: Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bilateral mastectomy	Procedure	Bilateral mastectomy and imaging study of cadaveric breasts	Male cadavers female cadavers

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female and male cadavers above 40 years

Exclusion Criteria:

Known breast cancer
Breast tissue accidental damage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	URL	Comment
https://doi.org/10.3892/mco.20	Study Protocol	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018567	Breast Neoplasms, Male

Ancestor Terms

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided