Breast Cancer
Conditions
Interventions
NGS-recommended group:None
Non-NGS-recommended group:None
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients definitively diagnosed with breast cancer at our center (Fudan University Shanghai Cancer Center) who have completed or are scheduled to undergo next-generation sequencing (NGS) testing in accordance with routine clinical practice; 2. Availability of formalin-fixed paraffin-embedded (FFPE) tissue samples suitable for whole-slide imaging (WSI); 3. Availability of definitive NGS reports encompassing the mutational status of target genomic alterations of interest in this study, including germline BRCA1/2 and somatic PIK3CA, ESR1, AKT1, and PTEN mutations or copy number loss (CNL).
Exclusion criteria
Exclusion criteria: 1. Suboptimal sample quality: Tissue specimens exhibiting severe autolysis, cautery artifacts, crush artifacts, or insufficient tumor cellularity (50% of the region of interest (ROI); pathologist annotations, air bubbles, or staining artifacts obscuring >50% of the ROI; or severe blurring, out-of-focus areas, or stitching errors that compromise the evaluation of cellular morphology and tissue architecture. 3. Missing or invalid data: Cases where NGS testing fails quality control, resulting in the inability to generate a conclusive report on gene mutational status. 4. Treatment interference: Tissue samples collected following neoadjuvant therapy that induced significant morphological alterations (e.g., profound treatment-reactive stromal fibrosis or tumor cell degeneration) severely compromising feature extraction by the AI model.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enrichment performance in the NGS-recommended population; | — |
Secondary
| Measure | Time frame |
|---|---|
| Enrichment performance in the overall model screen-positive population;Safety in the NGS-exempted population; | — |
Countries
China
Contacts
Public ContactZhimin Shao
Fudan University Shanghai Cancer Center
Outcome results
None listed