Clinical trial · Observational
Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Digital Pathology | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Virtual Staining | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Lymph node metastasis status
- timeFrame
- 2024-2025
- description
- Lymph node metastasis status: metastasis or non-metastasis
- measure
- Accuracy, Sensitivity, Specificity，Area under the curve，
- timeFrame
- 2024-2025
- description
- The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
- measure
- Positive predictive value，Negative predictive value
- timeFrame
- 2024-2025
- description
- The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available