Clinical trial NCT06517979: Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Official title: Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lymphatic Metastasis
Keywords: Artificial Intelligence
Lymph Node Metastasis
Digital Pathology
Whole Slide Image
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer, undergo radical tumor resection and lymph node dissection are planned to be enrolled in this diagnostic test. Histopathological slides of resected pelvic lymph nodes of enrolled patients will be collected and digitised as whole-slide images (WSIs) for the validation of the AI model.

Brief summary: The goal of this diagnostic test is to develop an artificial intelligence (AI)-based pan-cancer universal diagnostic model for detecting pathological lymph node metastasis (LNM), and prospectively evaluate its apllication value in the real-world clinical practice.

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 cancer LNM in in the real world.

Detailed description: Lymph node metastasis (LNM) is a common mode of cancer metastasis, 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 are to develope an artificial intelligence (AI)-based diagnostic model for detecting pathological cancer lymph node metastasis based on deep learning algorithms, and evaluate its apllication value in the real-world clinical settings.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with cancer, undergoing radical tumor resection and lymph node dissection.
* Patients with complete clinical and pathological information.

Exclusion Criteria:

* The patient refused to participate in this diagnostic test.

Primary outcomes:
measure: sensitivity
timeFrame: For each enrolled patient, the diagnosis results of AI model will be obtained in servel days after lymph node dissection, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
Secondary outcomes:
measure: specificity
timeFrame: For each enrolled patient, the diagnosis results of AI model will be obtained in servel days after lymph node dissection, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: