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

Breast Cancer Clinical Trial

— PROFILS  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757232
• Other study ID #: Etude PROFILS
• Status: Completed
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: February 2023
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumors' characterization using descriptive criteria of the BI-RADS classification	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	3 years
Secondary	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"	Chi 2 test or Fisher test for molecular profiles in both cohorts	3 years
Secondary	Description of molecular profiles in breast cancers detected only with ultrasound	Descriptive statistics concerning the selection of cancers	3 years