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NCT Number: NCT05757232

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

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,

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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"

    Time frame: 3 years

    Chi 2 test or Fisher test for molecular profiles in both cohorts

  2. Description of molecular profiles in breast cancers detected only with ultrasound

    Time frame: 3 years

    Descriptive statistics concerning the selection of cancers

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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)

Acronym: PROFILS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2023
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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