Clinical trial · Observational
Molecular Signature for Breast Cancer
Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic assistance tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Standard of care
- description
- Female patient diagnosed for breast cancer
- interventionNames
- Other: Diagnostic assistance tool
Primary outcomes (1)
- measure
- Diagnostic performances
- timeFrame
- at inclusion
- description
- The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity
Secondary outcomes (6)
- measure
- Duration of procedure
- timeFrame
- at inclusion
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available