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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02541188

Acronym

MediSein

Enrollment

460

Registered

2015-09-04

Start date

2014-10-02

Completion date

2017-01-02

Last updated

2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer

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.

Interventions

GENETICGenetic analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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)
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 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)
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 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 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026