NCT02480933

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
768

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

June 17, 2015

Last Update Submit

November 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Silent breast cancer prevalence

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

    2 years

Secondary Outcomes (1)

  • Silent breast cancer prevalent molecular profile

    2 years

Study Arms (2)

female cadavers

EXPERIMENTAL

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

Procedure: Bilateral mastectomyOther: Biopsy

Male cadavers

EXPERIMENTAL

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

Procedure: Bilateral mastectomyOther: Biopsy

Interventions

Bilateral mastectomy and imaging study of cadaveric breasts

Male cadaversfemale cadavers
BiopsyOTHER

Biopsy of BI-RADS 3 and superior lesions

Male cadaversfemale cadavers

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male cadavers above 40 years

You may not qualify if:

  • Known breast cancer
  • Breast tissue accidental damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms, Male

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 25, 2015

Study Start

September 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (https://doi.org/10.3892/mco.20)Access