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

NCT05757232 | Completed

• 1 other identifier: Etude PROFILS
• Study Type: observational
• Target: 203
• Locations: 0 countries
• Sites: N/A

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,

Conditions

Breast Cancer

Keywords

screening campaign; molecular profile; tomosynthesis; ultrasound; mammography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Breast cancers cases diagnosed with tomosynthesis and ultrasound

Brest cancers cases diagnosed with mammography and ultrasound

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source data base of the study is from the Association Régionale des Dépistages Organisés des Cancers (ARDOC) 203 breast cancer cases have been selected in a cohort of 19 246 women who participated to the nationale breast cancer screening campaign

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elsan: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: June 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 7, 2023

Record last verified: 2023-02