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

NCT02541188 | Terminated

• 1 other identifier: UF 9428
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Analysis TNM grade

  The day of inclusion

• Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)

  The day of inclusion

• analysis of hormone receptor ER

  The day of inclusion

• growth factors analysis (Ki 67)

  The day of inclusion

• analysis of HER2

  The day of inclusion

Study Arms (2)

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

Interventions

Genetic analysis GENETIC

Breast cancer in young women in the western countries; breast cancer in young women is in the Maghreb

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Pascal PUJOL, MDPhD

  Oncogenetic Unit -CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 4, 2015
• Study Start: October 2, 2014
• Primary Completion: October 2, 2016
• Study Completion: January 2, 2017
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

FR (1)