Clinical trial NCT06486155: Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
Official title: Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Virtual Staining
Lymph Node Metastasis
Breast Cancer
Digital Pathology
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2024-07-03
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lymph node metastasis status
timeFrame: 2024-2025
measure: Accuracy, Sensitivity, Specificity，Area under the curve，
timeFrame: 2024-2025
measure: Positive predictive value，Negative predictive value
timeFrame: 2024-2025
Secondary outcomes:
measure: Peak Signal-to-Noise Ratio(PSNR)
timeFrame: 2024-2025
measure: Multi-Scale Structural Similarity (MS-SSIM)
timeFrame: 2024-2025
measure: Pearson correlation coefficient
timeFrame: 2024-2025
Other outcomes:
Locations:
Study officials:
References: