Female Breast CancerSISYPHUSNCT02480933
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
A study testing Bilateral mastectomy and Biopsy in people with Female Breast Cancer and Male Breast Cancer, run by Centro Hospitalar Lisboa Ocidental.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Female Breast Cancer, Male Breast Cancer
- What is being tested?
- Bilateral mastectomy and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male cadavers above 40 years
Who cannot join
- Known breast cancer
- Breast tissue accidental damage
About this study
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.
- Conditions
- Female Breast Cancer, Male Breast Cancer
- Being tested
- Bilateral mastectomy, Biopsy
- Medical subject headings
- Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral mastectomyProcedure or surgery
Bilateral mastectomy and imaging study of cadaveric breasts
BiopsyOther
Biopsy of BI-RADS 3 and superior lesions
| Study group | Role | What they receive |
|---|---|---|
| female cadavers | Experimental | female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy Receives: Procedure: Bilateral mastectomy; Other: Biopsy |
| Male cadavers | Experimental | male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy Receives: Procedure: Bilateral mastectomy; Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silent breast cancer prevalence
To define the existing disease that did not caused death in both sexes
Measured: 2 years
Secondary outcomes (1)
Silent breast cancer prevalent molecular profile
To identify those molecular subgroups of the disease that remain silent
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Ocidental
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
- Responsible party
- Principal investigator, Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480933
- Sponsor's protocol ID
- CentroHLO
- Acronym
- SISYPHUS
- Status last verified
- Nov 2017
- First submitted
- 17 Jun 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
- ClinicalTrials.gov ID
- NCT02480933
- Acronym / sponsor ID
- SISYPHUS / CentroHLO
- Conditions
- Female Breast Cancer, Male Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- Centro Hospitalar Lisboa OcidentalOther government
- Collaborators
- Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female cadavers | Experimental | Procedure: Bilateral mastectomy, Other: Biopsyfemale cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy |
| Male cadavers | Experimental | Procedure: Bilateral mastectomy, Other: Biopsymale cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female and male cadavers above 40 years
Key exclusion criteria (2 listed)
- Known breast cancer
- Breast tissue accidental damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral mastectomyBilateral mastectomy and imaging study of cadaveric breasts | Procedure or surgery | Male cadavers, female cadavers |
| BiopsyBiopsy of BI-RADS 3 and superior lesions | Other | Male cadavers, female cadavers |
Primary outcome
Silent breast cancer prevalence
Time frame: 2 years
To define the existing disease that did not caused death in both sexes
1 secondary outcome
Silent breast cancer prevalent molecular profile
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral mastectomy and Biopsy in people with Female Breast Cancer and Male Breast Cancer, run by Centro Hospitalar Lisboa Ocidental.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silent breast cancer prevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.