Construction of an Ultrasound Profile and a Mammographic Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05757232
• Lead Sponsor: Elsan

Brief Summary

PROFILS is a retrospective, exploratory study on data collected in 203 breast cancer cases diagnosed during a national screening campaign from 2015 to 2018.

The aim of the study is to analyse histological, clinical and radiological data collected during the screening campaign to build an ultrasound profile and a mammographic profile corresponding to brest cancers' different molecular sub-types (Luminal A, Luminal B, HER2+, Triple negative) using the BI-RADS classification.

The study has the following objectives:

* To compare molecular profiles of breast cancers detected in a cohort of women diagnosed with tomosynthesis and ultrasound with molecular profiles of brest cancers detected in the cohort of women diagnosed with classical mammography and ultrasound

* To describe molecular profiles of cancers detected only with ultrasound,

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2023-02
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-24
• Last Update Submitted: 2023-02-24
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

Inclusion Criteria

• Women diagnosed with a breast cancer
• Detection of a breast cancer during the screening campaign organized between june 2015 and july 2018 in the following geographic zones : Cantal, Haute Loire and Puys de Dôme

Exclusion Criteria

• Patients who expressed their opposition to the use of their personal data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumors' characterization using descriptive criteria of the BI-RADS classification	3 years	The primary outcome will be tumors' characterization using descriptive criteria of the BI-RADS classification within the framework of a mammography and an ultrasound, and then the research of a correlation with the molecular profile in 203 patientes diagnosed with a breast cancer

Secondary Outcome Measures

Name	Time	Method
Comparison of molecular profiles of breast cancers detected in the cohorte "mammography and ultrasound" with molecular profiles of breast cancers detected in the cohorte "tomosynthesis and ultrasound"	3 years	Chi 2 test or Fisher test for molecular profiles in both cohorts
Description of molecular profiles in breast cancers detected only with ultrasound	3 years	Descriptive statistics concerning the selection of cancers