Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with cancer, undergoing radical tumor resection and lymph node dissection.

Patients with complete clinical and pathological information.

Disqualifiers

The patient refused to participate in this diagnostic test.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Artificial intelligence (AI)-based diagnostic model

    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.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Patients with cancer undergoing LND1 intervention

Trial outcomes

Primary outcomes

1

sensitivity

the number of correctly diagnosed positive slides (with lymphatic metastasis), to be divided by the number of positive slides in total

Time frame
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

1

specificity

the number of correctly diagnosed negative slides (without lymphatic metastasis), to be divided by the number of negative slides in total

Time frame
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

Sponsors and contacts

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