Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience

August 1, 2017 updated by: Syrine Abdeljaoued, Salah Azaïz Cancer Institute

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Salah Azaïz Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Histological diagnosis of male breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: Through study completion, an average of 4 year
Survival, Disease free survival
Through study completion, an average of 4 year
Clinico-biological characteristics of the disease
Time Frame: Through study completion, an average of 4 year
Through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salah Azaïz Cancer Institute

Investigators

  • Study Chair: Syrine Abdeljaoued, PhD, Salah Azaïz Cancer Institute
  • Principal Investigator: Ilhem Bettaieb, Dr, Salah Azaïz Cancer Institute
  • Principal Investigator: Amor Gamoudi, Pr, Salah Azaïz Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalahSCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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