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

Terminated

• Conditions: Breast Cancer
• Interventions: Genetic: Genetic analysis

• Registration Number: NCT02541188
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

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 Timeline

• Study Start: 2014-10-02
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Primary Completion: 2016-10-02
• Study Completion: 2017-01-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 460

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast cancer in young women is in the Maghreb	Genetic analysis	breast cancer in young women (\< 40years old) is in the Maghreb
Breast cancer in young women in the western countries	Genetic analysis	Breast cancer in young women (\< 40years old) in the western countries

Primary Outcome Measures

Name	Time	Method
Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)	The day of inclusion
Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)	The day of inclusion

Secondary Outcome Measures

Name	Time	Method
analysis of HER2	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)
Analysis TNM grade	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)
growth factors analysis (Ki 67)	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)
analysis of hormone receptor PR	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)
Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)	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)
analysis of hormone receptor ER	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)

Trial Locations

Locations (1)

CHU de Montpellier; 🇫🇷 Montpellier, France