Molecular Signature for Breast Cancer

Breast Cancer Clinical Trial

— MoSi4BCa  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724407
• Other study ID #: APHP211593
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe Bertheau
• Phone: +3342494135
• Email: philipppe.bertheau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	inter-rater agreement	Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient	at inclusion
Secondary	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