Molecular Signature for Breast Cancer (MoSi4BCa)

February 2, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performances
Time Frame: 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
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of procedure
Time Frame: 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)
at inclusion
Cognitive savings
Time Frame: 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.
at inclusion
General comfort of use
Time Frame: 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.
at inclusion
Organizational constraints
Time Frame: 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.
at inclusion
inter-rater agreement
Time Frame: at inclusion
Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient
at inclusion
Diagnostic performances
Time Frame: 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
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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