Molecular Signature for Breast Cancer

NCT05724407 | Unknown

• 1 other identifier: APHP211593
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of procedure

  at inclusion

• Cognitive savings

  at inclusion

• General comfort of use

  at inclusion

• Organizational constraints

  at inclusion

• inter-rater agreement

  at inclusion

Study Arms (1)

Standard of care

Female patient diagnosed for breast cancer

Other: Diagnostic assistance tool

Interventions

Diagnostic assistance tool 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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female breast cancer patient

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Philippe Bertheau

CONTACT

+3342494135; philipppe.bertheau@aphp.fr

Matthieu RESCHE-RIGON

CONTACT

+33142499742; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-01