Clinical trial · Observational
Prospective Validation of Pathology-based Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in Prostate Cancer
- 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 diagnostic test is to prospectively test the performance of pre-developed artificial intelligence (AI) diagnostic model for detecting pathological lymph node metastasis (LNM) of prostate cancer. Investigators had developed this AI model based on deep learning algorithms in preliminary research, and it performed well in retrospective tests. Investigators will compare the diagnostic performance (sensitivity, specificity, etc.) of the AI model and routine pathological report issued by pathologists, to see if the AI model can improve the clinical workflow of pathological evaluation of LNM in prostate cancer in the real world.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial intelligence (AI)-based diagnostic model (developed) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing PLND
- description
- Patients (will) undergo radical prostatectomy and pelvic lymph node dissection
- interventionNames
- Diagnostic Test: Artificial intelligence (AI)-based diagnostic model (developed)
Primary outcomes (1)
- measure
- sensitivity
- timeFrame
- For each enrolled patient, the diagnosis results of AI model will be obtained in not long after pelvic lymph node dissection, and the sensitivity of the AI model will be evaluated through study completion, an average of 2 year.
- description
- the number of correctly diagnosed positive slides (with lymphatic metastasis), to be divided by the number of positive slides in total
Secondary outcomes (1)
- measure
- specificity
- timeFrame
- For each enrolled patient, the diagnosis results of AI model will be obtained in not long after pelvic lymph node dissection, and the specificity of the AI model will be evaluated through study completion, an average of 2 year.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients with prostate cancer, undergoing radical prostatectomy and pelvic lymph node dissection. * Patients with complete clinical and pathological information. Exclusion Criteria: * Patients with other tumors that metastasized to pelvic lymph nodes. * The patient refused to participate in this diagnostic test.
References
Publications (0)
Data not yet available