Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,200
- 主要终点
- Positive predictive value，Negative predictive value
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy/axillary lymph node dissection; Lymph nodes with clear postoperative paraffin pathological results.
- •Patients aged 18-75 with one of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, or cervix; Undergoing surgical resection of lymph nodes; Lymph nodes with clear postoperative paraffin pathological results.
- •Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy; Sentinel lymph nodes with clear postoperative paraffin pathological results.
排除标准
- •Part 1 / Part 2:
- •Lymph node diagnosis is missing; Absence of lymph node component in the slice.
- •Sentinel lymph node diagnosis is missing; Absence of lymph node component in the frozen slice.
结局指标
主要结局
Positive predictive value，Negative predictive value
时间窗: 2024-2025
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Lymph node metastasis status
时间窗: 2024-2025
Lymph node metastasis status: metastasis or non-metastasis
Accuracy, Sensitivity, Specificity，Area under the curve，
时间窗: 2024-2025
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
次要结局
- Pearson correlation coefficient(2024-2025)
- Peak Signal-to-Noise Ratio(PSNR)(2024-2025)
- Multi-Scale Structural Similarity (MS-SSIM)(2024-2025)