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Trial record 1 of 1 for:    MoSi4BCa
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Molecular Signature for Breast Cancer (MoSi4BCa)

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ClinicalTrials.gov Identifier: NCT05724407
Recruitment Status : Not yet recruiting
First Posted : February 13, 2023
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Other: Diagnostic assistance tool

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. inter-rater agreement [ Time Frame: at inclusion ]
    Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female breast cancer patient
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05724407


Contacts
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Contact: Philippe Bertheau +3342494135 philipppe.bertheau@aphp.fr
Contact: Matthieu RESCHE-RIGON +33142499742 matthieu.resche-rigon@u-paris.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05724407    
Other Study ID Numbers: APHP211593
First Posted: February 13, 2023    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases