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Clinical Trials/NCT05757232
NCT05757232CompletedNot Applicable

Construction of an Ultrasound Profile and a Mammography Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study of 203 Cases Diagnosed During the National Screening Campaign in 2015-2018 (PROFILS)

Elsan0 sites203 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
203
Primary Endpoint
Tumors' characterization using descriptive criteria of the BI-RADS classification

Study Overview

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,

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Tumors' characterization using descriptive criteria of the BI-RADS classification

Time Frame: 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 Outcomes

  • 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)
  • Description of molecular profiles in breast cancers detected only with ultrasound(3 years)

Investigators

Sponsor
Elsan
Sponsor Class
Other
Responsible Party
Sponsor

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