NCT03240510

Brief 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 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

July 28, 2017

Last Update Submit

August 1, 2017

Conditions

Male Breast Cancer

Keywords

Breast cancerMale

Outcome Measures

Primary Outcomes (2)

  • Clinical outcomes

    Survival, Disease free survival

    Through study completion, an average of 4 year

  • Clinico-biological characteristics of the disease

    Through study completion, an average of 4 year

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Histological diagnosis of male breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salah Azaïz Cancer Institute

Tunis, Tunisia

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Syrine Abdeljaoued, PhD

    Salah Azaïz Cancer Institute

    STUDY CHAIR

  • Ilhem Bettaieb, Dr

    Salah Azaïz Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Amor Gamoudi, Pr

    Salah Azaïz Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Oncology, Study Chair

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 7, 2017

Study Start

January 1, 2014

Primary Completion

December 31, 2016

Study Completion

January 1, 2018

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

TU(1)