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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Lymph node metastasis status
Lymph node metastasis status: metastasis or non-metastasis
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
Positive predictive value,Negative predictive value
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Secondary outcomes
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
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
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
Locations
Sponsors and contacts
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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: