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.
Study Type
OBSERVATIONAL
Enrollment
220
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). Each anatomo-histopathological slide will be re-read 3 times: * Reading 1: first reading by a pathologist in the care setting * Reading via the standard care procedure (microscope and physical slides) * Reading 2: Second reading by another pathologist from the same center, as part of the research. * Reading via the standard procedure of care (microscope and physical slides) * Reading 3: Third reading by the initial physician, with the algorithmic tool MoSi4BCa after digitization of the slides by a laboratory technician and after a wash-out period of 2 months.
Diagnostic performances
The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity
Time frame: at inclusion
Duration of procedure
Comparison of medical time spent reading the slide and establishing marker identification between the standard of care method (microscope and pathologist alone) and the automatic marker scoring support tool (MoSi4BCa)
Time frame: at inclusion
Cognitive savings
The contribution of the tool in terms of cognitive savings will be evaluated using quantitative survey for the pathologists participating in the study.
Time frame: at inclusion
General comfort of use
The contribution of the tool in terms of general comfort of use will be evaluated using quantitative survey for the pathologists participating in the study.
Time frame: at inclusion
Organizational constraints
The organizational constraints of the integration of the solution will be evaluated using a specific questionnaire dedicated to the pathologists and laboratory technicians who participated in the implementation and preparation of the installations.
Time frame: at inclusion
inter-rater agreement
Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient
Time frame: at inclusion
Diagnostic performances
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Diagnostic performances will be assessed using positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value, and C-index or Area Under the Curve
Time frame: at inclusion