Genotype and Phenotype in Early Onset Breast Cancer in Young Women on the Two Shores of the Mediterranean Sea (MediSein)

December 9, 2021 updated by: University Hospital, Montpellier
Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The object of this study is to compare the genotypic and phenotypic differences between south and north shore of the mediterranean sea.

Study Type

Observational

Enrollment (Actual)

460

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

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier

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

Female

Sampling Method

Probability Sample

Study Population

Patients have or have had a breast cancer diagnosed before 40 years old in two shores of the Mediterranean sea (France, lgeria, Marocco, Egypt, Tunisia)

Description

Inclusion Criteria:

  • Patient have or have had a breast cancer diagnosed before 40 years old
  • Breast cancer proven by histology
  • BRCA1/2 analysis proposed, realized, ongoing
  • Women >18 years old
  • Patient with insurance
  • Patient informed and no-opposed

Exclusion Criteria:

  • Patient have or have had a breast cancer diagnosed after 40 years old
  • Patient requiring tutorship or guardianship
  • Adult patient protected by law

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
breast cancer in young women is in the Maghreb
breast cancer in young women (< 40years old) is in the Maghreb
Genetic: Genetic analysis
Breast cancer in young women in the western countries
Breast cancer in young women (< 40years old) in the western countries
Genetic: Genetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)
Time Frame: The day of inclusion
The day of inclusion
Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)
Time Frame: The day of inclusion
The day of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis TNM grade
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion
Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion
analysis of hormone receptor ER
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion
growth factors analysis (Ki 67)
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion
analysis of HER2
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion
analysis of hormone receptor PR
Time Frame: The day of inclusion
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
The day of inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Pascal PUJOL, MDPhD, Oncogenetic Unit -CHU de Montpellier

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)

October 2, 2014

Primary Completion (Actual)

October 2, 2016

Study Completion (Actual)

January 2, 2017

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9428

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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