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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02541188
• Collaborator: (none)
• Enrollment: 460
• Location: 1
• Actual Duration (Months): 27
• Patients Per Site Per Month: 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: Genetic analysis

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 Design

• Study Type: Observational
• Actual Enrollment: 460 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Actual Study Start Date: Oct 2, 2014
• Actual Primary Completion Date: Oct 2, 2016
• Actual Study Completion Date: Jan 2, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1) [The day of inclusion]

2. Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2) [The day of inclusion]

Secondary Outcome Measures

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Montpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02541188
• Other Study ID Numbers: UF 9428
• First Posted: Sep 4, 2015
• Last Update Posted: Dec 10, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by University Hospital, Montpellier: Breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 10, 2021