NCT06486155

Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Yunnan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are: Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes? Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients? Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.

Conditions

• Virtual Staining
• Lymph Node Metastasis
• Breast Cancer
• Digital Pathology

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-07-03
• Last updated: 2024-08-13