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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Female patient diagnosed for breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic assistance tool | Other | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at inclusion |
| Cognitive savings |
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Inclusion Criteria:
Exclusion Criteria:
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Female breast cancer patient
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Bertheau | Contact | +3342494135 | philipppe.bertheau@aphp.fr | |
| Matthieu RESCHE-RIGON | Contact | +33142499742 | matthieu.resche-rigon@u-paris.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The contribution of the tool in terms of cognitive savings will be evaluated using quantitative survey for the pathologists participating in the study. |
| 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. | 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. | at inclusion |
| inter-rater agreement | Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient | at inclusion |
| Diagnostic performances | 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 | at inclusion |
| D017437 |
| Skin and Connective Tissue Diseases |