Breast Cancer
Conditions
Brief summary
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.
Interventions
OTHERDiagnostic assistance tool
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performances | at inclusion | The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General comfort of use | at inclusion | 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. |
| Duration of procedure | at inclusion | 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) |
| Cognitive savings | at inclusion | The contribution of the tool in terms of cognitive savings will be evaluated using quantitative survey for the pathologists participating in the study. |
| inter-rater agreement | at inclusion | Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient |
| Diagnostic performances | at inclusion | 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 |
| Organizational constraints | at inclusion | 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. |
Contacts
Primary ContactPhilippe Bertheau
Backup ContactMatthieu RESCHE-RIGON
Outcome results
None listed