Actively Recruiting
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-11-28
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are developing an artificial intelligence (AI)-based diagnostic model to detect pathological lymph node metastasis (LNM) across various cancers. The study aims to evaluate this AI model's diagnostic performance compared to routine pathological reports by pathologists, with the goal of improving the clinical workflow in real-world settings. Accurate lymph node staging after cancer surgery is crucial for treatment decisions and prognosis, but current manual evaluations can miss small metastatic lesions and are time-consuming. This observational diagnostic study involves collecting pathological slides from patients undergoing radical tumor resection and lymph node dissection. These slides are digitized into whole-slide images (WSIs), which the AI model analyzes to produce detailed heatmaps and slide-level diagnoses indicating the presence or absence of LNM. Routine pathological examinations proceed independently, and any discrepancies between AI and pathology results are reviewed by senior pathologists, using additional tests if needed, to decide the final diagnosis presented in the patient's pathology report. Participants provide pathological samples as part of their standard surgery, with no additional interventions required. Researchers collect diagnostic results from the AI model over an average of three years to assess sensitivity and specificity. The study monitors how well the AI detects LNM compared to traditional pathology, aiming to enhance diagnostic accuracy and efficiency in cancer care.
CONDITIONS
Brief Title
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cancer, undergoing radical tumor resection and lymph node dissection.
- Patients with complete clinical and pathological information.
You will not qualify if you...
- The patient refused to participate in this diagnostic test.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Several days after lymph node dissection
Participants undergo radical tumor resection and lymph node dissection. Pathological slides of resected lymph nodes are collected and digitised into whole-slide images. The AI model analyses these images to generate diagnostic results, which are compared with routine pathological examination results.
1 visit (in-person) for surgery and tissue collection
Duration - Approximately 3 years
Participants are followed for approximately 3 years to evaluate the sensitivity and specificity of the AI diagnostic model based on pathological results.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
L
Lin Tianxin, Ph.D
W
Wu Shaoxu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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