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

Breast Cancer Clinical Trial

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Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541188
• Other study ID #: UF 9428
• Status: Terminated
• Start date: October 2, 2014
• Est. completion date: January 2, 2017

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 460
• Est. completion date: January 2, 2017
• Est. primary completion date: October 2, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Genetic analysis

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)		The day of inclusion
Primary	Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)		The day of inclusion
Secondary	Analysis TNM grade	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
Secondary	Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)	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
Secondary	analysis of hormone receptor ER	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
Secondary	growth factors analysis (Ki 67)	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
Secondary	analysis of HER2	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
Secondary	analysis of hormone receptor PR	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