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Molecular Signature for Breast Cancer

NCT05724407 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2023-02-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2023-11-30
Completion
2023-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724407 on ClinicalTrials.gov