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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.
Lymph node metastasis (LNM) is a common mode of metastasis in prostate cancer, and accurate postoperative pathological lymph node staging is of great significance for further treatment and prognosis assessment. However, the current pathological evaluation of lymph nodes relies on manual examination by pathologists, which has a relatively low diagnostic efficiency and is prone to missed-diagnosis for micro metastatic lesions. Therefore, investigators developed an AI diagnostic model for detecting pathological lymph node metastasis of prostate cancer based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.
This study is a diagnostic test with no intervention measures, planning to collect pathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images (WSIs). The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results (with or without LNM). The routine pathological examination will be performed as usual. These two processes will not interfere with each other. And if there are inconsistency in slide-level classification between AI and routine pathological examination, investigators would convene senior pathologists for discussion to make the final decision (immunohistochemistry would be performed if necessary). The final result will be presented to the patient in the form of a pathological report.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing PLND | Patients (will) undergo radical prostatectomy and pelvic lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial intelligence (AI)-based diagnostic model (developed) | Diagnostic Test | Collect pathological slides of resected lymph nodes of the enrolled patients. Digitise these slides into whole-slide images (WSIs). Analyze the WSIs using the AI model to generate diagnostic results (with or without lymphatic metastasis). No intervention to patients would be performed in this diagnostic test study. |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity | the number of correctly diagnosed positive slides (with lymphatic metastasis), to be divided by the number of positive slides in total | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| specificity | the number of correctly diagnosed negative slides (without lymphatic metastasis), to be divided by the number of negative slides in total | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with prostate cancer, (will) undergo radical prostatectomy and pelvic lymph node dissection between Jan, 2024 and Dec 2025 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University are planned to be enrolled in this prospective diagnostic test. Histopathological slides of resected pelvic lymph nodes of enrolled patients will be collected and digitised as whole-slide images (WSIs) for prospective validation of the AI model.
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| Name | Affiliation | Role |
|---|---|---|
| Tianxin Lin, Ph.D | Department of Urology of Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
To protect patient privacy, pathological slide images and other patient-related data are not publicly accessible.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2025 | Feb 4, 2026 |
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Histopathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from patients with prostate cancer undergoing radical prostatectomy and pelvic lymph node dissection.
|
| Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2025 | Feb 4, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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