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

Not yet recruiting

• Conditions: Lymph Node Metastasis; Virtual Staining; Breast Cancer; Digital Pathology

• Registration Number: NCT06486155
• Lead Sponsor: Yunnan Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-08
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

Part 1:

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.

Part 2:

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.

Part 3:

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.

Exclusion Criteria

Part 1 / Part 2:

Lymph node diagnosis is missing; Absence of lymph node component in the slice.

Part 3:

Sentinel lymph node diagnosis is missing; Absence of lymph node component in the frozen slice.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive predictive value，Negative predictive value	2024-2025	The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Lymph node metastasis status	2024-2025	Lymph node metastasis status: metastasis or non-metastasis
Accuracy, Sensitivity, Specificity，Area under the curve，	2024-2025	The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images

Secondary Outcome Measures

Name	Time	Method
Pearson correlation coefficient	2024-2025	Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes
Peak Signal-to-Noise Ratio(PSNR)	2024-2025	Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to infinity, the higher scores mean the better outcomes
Multi-Scale Structural Similarity (MS-SSIM)	2024-2025	Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes