<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240510</url>
  </required_header>
  <id_info>
    <org_study_id>SalahSCI</org_study_id>
    <nct_id>NCT03240510</nct_id>
  </id_info>
  <brief_title>Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience</brief_title>
  <official_title>Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salah Azaïz Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salah Azaïz Cancer Institute</source>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer&#xD;
      patients population over a period of 14 years.&#xD;
&#xD;
      Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of&#xD;
      male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from&#xD;
      2004 to 2013.&#xD;
&#xD;
      Goal of the prospective part: to create a registry of male patients with breast cancer for a&#xD;
      period of 48 months (from 2014 to 2017).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
    <description>Survival, Disease free survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinico-biological characteristics of the disease</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Male Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective part: All men with histologically proven invasive breast carcinoma diagnosed&#xD;
        between 2004 and 2013.&#xD;
&#xD;
        Prospective part: All men with histologically proven invasive breast carcinoma diagnosed&#xD;
        between 2014 and 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Histological diagnosis of male breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Syrine Abdeljaoued, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Salah Azaïz Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ilhem Bettaieb, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salah Azaïz Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amor Gamoudi, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salah Azaïz Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salah Azaïz Cancer Institute</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Salah Azaïz Cancer Institute</investigator_affiliation>
    <investigator_full_name>Syrine Abdeljaoued</investigator_full_name>
    <investigator_title>PhD in Oncology, Study Chair</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Male</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240510
org study id: SalahSCI
nct id: NCT03240510
lead sponsor: 
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).
observational model: Case-Only
time perspective: Prospective
measure: Clinical outcomes
time frame: Through study completion, an average of 4 year
description: Survival, Disease free survival
measure: Clinico-biological characteristics of the disease
time frame: Through study completion, an average of 4 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Syrine Abdeljaoued, PhD
role: Study Chair
affiliation: Salah Azaïz Cancer Institute
last name: Ilhem Bettaieb, Dr
role: Principal Investigator
affiliation: Salah Azaïz Cancer Institute
last name: Amor Gamoudi, Pr
role: Principal Investigator
affiliation: Salah Azaïz Cancer Institute
facility: 
country: Tunisia
responsible party type: Principal Investigator
investigator affiliation: Salah Azaïz Cancer Institute
investigator full name: Syrine Abdeljaoued
investigator title: PhD in Oncology, Study Chair
mesh term: Breast Neoplasms
mesh term: Breast Neoplasms, Male
sharing ipd: Undecided