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Trial Title:
Molecular Signature for Breast Cancer
NCT ID:
NCT05724407
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Diagnostic assistance tool
Description:
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.
Arm group label:
Standard of care
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.
Criteria for eligibility:
Study pop:
Female breast cancer patient
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724407
