Molecular Signature for Breast Cancer

NCT ID: NCT05724407

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Standard of care

Female patient diagnosed for breast cancer

Diagnostic assistance tool

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Philippe Bertheau

Role: CONTACT

+3342494135

Matthieu RESCHE-RIGON

Role: CONTACT

+33142499742

Other Identifiers

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APHP211593

Identifier Type: -

Identifier Source: org_study_id

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