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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorYunnan Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Lymph node metastasis status

Lymph node metastasis status: metastasis or non-metastasis

Time frame
2024-2025
2

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

Time frame
2024-2025
3

Positive predictive value,Negative predictive value

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

Time frame
2024-2025

Secondary outcomes

1

Peak Signal-to-Noise Ratio(PSNR)

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

Time frame
2024-2025
2

Multi-Scale Structural Similarity (MS-SSIM)

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

Time frame
2024-2025
3

Pearson correlation coefficient

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

Time frame
2024-2025

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunnan Cancer Hospital

Lead sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

This trial is not recruiting at the moment. You can still explore other options: