- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480933
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens (SISYPHUS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female and male cadavers above 40 years
Exclusion Criteria:
- Known breast cancer
- Breast tissue accidental damage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: female cadavers
female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
|
Bilateral mastectomy and imaging study of cadaveric breasts
Biopsy of BI-RADS 3 and superior lesions
|
Experimental: Male cadavers
male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy
|
Bilateral mastectomy and imaging study of cadaveric breasts
Biopsy of BI-RADS 3 and superior lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Silent breast cancer prevalence
Time Frame: 2 years
|
To define the existing disease that did not caused death in both sexes
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Silent breast cancer prevalent molecular profile
Time Frame: 2 years
|
To identify those molecular subgroups of the disease that remain silent
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CentroHLO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
-
Study Protocol
Information identifier: https://doi.org/10.3892/mco.20Information comments: feasibility of the protocol paper
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Male Breast Cancer
-
University of WashingtonNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast CancerUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Organon and CoInstitute for Applied Economics and Health Research ApsCompleted
-
German Breast GroupPfizerCompletedMale Breast CancerGermany
-
Salah Azaïz Cancer InstituteUnknownMale Breast CancerTunisia
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)WithdrawnHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast CancerUnited States
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedMale Breast Cancer | Breast - FemaleUnited States
-
National Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Bilateral mastectomy
-
Severance HospitalSamsung Medical Center; Asan Medical Center; Kyungpook National University Chilgok...RecruitingBreast Neoplasms | Benign Breast Disease | Germline BRCA1 Gene Mutation | Germline BRCA2 Gene Mutation | Germline Mutation AbnormalityKorea, Republic of
-
Beijing Friendship HospitalUnknown
-
Severance HospitalSamsung Medical Center; Changhua Christian Hospital; European Institute of OncologyCompletedRecurrence | Postoperative Complications | Breast Cancer | Breast Neoplasms | Surgery | Surgery--Complications | BRCA1 Mutation | BRCA2 MutationKorea, Republic of
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Completed
-
Yale UniversityActive, not recruitingBreast CancerUnited States
-
Changhua Christian HospitalMinistry of Science and Technology, Taiwan; Intuitive SurgicalRecruiting
-
Invuity, Inc.Montefiore Medical CenterUnknown
-
Zagazig UniversityCompletedBreast NeoplasmsEgypt
-
University of Alabama at BirminghamRecruiting
-
Brust-Zentrum AGCompleted