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

NCT06486155 | Not Yet Recruiting

• 1 other identifier: KYLX2024-129
• Study Type: observational
• Target: 2,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Lymph node metastasis status

  Lymph node metastasis status: metastasis or non-metastasis

  2024-2025

• Accuracy, Sensitivity, Specificity，Area under the curve，

  The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images

  2024-2025

• Positive predictive value，Negative predictive value

  The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images

  2024-2025

Secondary Outcomes (3)

• Peak Signal-to-Noise Ratio(PSNR)

  2024-2025

• Multi-Scale Structural Similarity (MS-SSIM)

  2024-2025

• Pearson correlation coefficient

  2024-2025

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Part 1: The investigators plan to collect 1000 patients with breast cancer. Part 2: The investigators plan to collect 100 patients with each of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, and cervix. The total number of patients will be 800. Part 3: The investigators plan to prospectively collect 400 patients with breast cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator

MeSH Terms

Conditions

Lymphatic Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-06