Molecular Signature for Breast Cancer (MoSi4BCa)

Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Diagnostic assistance tool

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

• Study Contact: Name: Philippe Bertheau; Phone Number: +3342494135; Email: philipppe.bertheau@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female breast cancer patient

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Standard of care; Female patient diagnosed for breast cancer

Other: Diagnostic 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 settingReading 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: APHP211593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No