Molecular Signature for Breast Cancer (MoSi4BCa)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Other: Diagnostic assistance tool

Study type: Observational

Funder types: Other

Identifiers

NCT05724407

APHP211593

Details and patient eligibility

About

The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Understanding French
• With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
• First diagnosis of invasive breast cancercarcinoma
• Affiliated to a social security system
• Agreeing to participate in the study

Exclusion criteria

• Refusal to participate in the study
• Not affiliated to the social security system
• Minor or under legal protection
• Patient with a history of breast cancer
• Patient previously treated for breast cancer
• Patient who has relapsed from breast cancer treatment
• Non ductal or non lobular invasive breast cancer carcinoma

Trial design

220 participants in 1 patient group

Standard of care

Description:

Female patient diagnosed for breast cancer

Treatment:

Other: Diagnostic assistance tool