Male Breast CancerNCT03240510
Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience
An observational study of Male Breast Cancer, run by Salah Azaïz Cancer Institute at 1 site in Tunisia.
Trial summary
The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer patients population over a period of 14 years. Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Breast Cancer
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2014to 1 Jan 2018
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective part: All men with histologically proven invasive breast carcinoma diagnosed between 2004 and 2013. Prospective part: All men with histologically proven invasive breast carcinoma diagnosed between 2014 and 2017.
Who may be able to join
- Histological diagnosis of male breast cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer patients population over a period of 14 years.
Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from 2004 to 2013.
Goal of the prospective part: to create a registry of male patients with breast cancer for a period of 48 months (from 2014 to 2017).
- Conditions
- Male Breast Cancer
- Keywords
- Breast cancer, Male
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Survival, Disease free survival
Measured: Through study completion, an average of 4 year
Clinico-biological characteristics of the disease
Measured: Through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salah Azaïz Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syrine Abdeljaoued, Salah Azaïz Cancer Institute
- Investigators
- Syrine Abdeljaoued, PhD, Study chair, Salah Azaïz Cancer InstituteIlhem Bettaieb, Dr, Principal investigator, Salah Azaïz Cancer InstituteAmor Gamoudi, Pr, Principal investigator, Salah Azaïz Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240510
- Sponsor's protocol ID
- SalahSCI
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience
- ClinicalTrials.gov ID
- NCT03240510
- Acronym / sponsor ID
- SalahSCI
- Conditions
- Male Breast Cancer
- Keywords
- Breast cancer, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Salah Azaïz Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 7 Aug 2017 (actual)
- 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 goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer patients population over a period of 14 years.
Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from 2004 to 2013.
Goal of the prospective part: to create a registry of male patients with breast cancer for a period of 48 months (from 2014 to 2017).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective part: All men with histologically proven invasive breast carcinoma diagnosed between 2004 and 2013. Prospective part: All men with histologically proven invasive breast carcinoma diagnosed between 2014 and 2017.
Key inclusion criteria (1 listed)
- Histological diagnosis of male breast cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcomes
Time frame: Through study completion, an average of 4 year
Survival, Disease free survival
Clinico-biological characteristics of the disease
Time frame: Through study completion, an average of 4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Syrine Abdeljaoued, PhD study chair
Salah Azaïz Cancer Institute
Ilhem Bettaieb, Dr principal investigator
Salah Azaïz Cancer Institute
Amor Gamoudi, Pr principal investigator
Salah Azaïz Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Breast Cancer, run by Salah Azaïz Cancer Institute at 1 site in Tunisia.
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 0 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical outcomes (time frame: Through study completion, an average of 4 year). The study lists 2 primary outcomes in all. 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 7 Aug 2017.