Molecular Signature for Breast Cancer

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Other: Diagnostic assistance tool

• Registration Number: NCT05724407
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13
• Study Start: 2023-03
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	Diagnostic assistance tool	Female patient diagnosed for breast cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
inter-rater agreement	at inclusion	Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient
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.