Optimising Renal Tumour Management Through Artificial Intelligence Modules

Официальное название

Mutimodal Artificial Intelligence for Optimising Renal Tumour Management: Diagnosis, Surgery and Prognosis

Обзор

The goal of this observational study is to improve the management of people with renal tumour by multimodal artificial intelligence(AI). It will also measure the accuracy of the predictions from AI models. The main questions it aims to answer are: 1. whether the AI module can accurately provide tumor-related information such as Benign or malignant, subtypes, grading, stage, etc. by learning from preoperative CT images. 2. whether the AI module can help clinicians find out the most suitable surgical programme for people with renal tumor. 3. whether the AI module can integrate CT images and pathology slides, offering supplementary prognostic information to improve postoperative survival. Participants who complete a CT(usually Contrast-enhanced CT, CECT) examination and undergo radical or partial nephrectomy will carry out active surveillance and record postoperative survival data for 5 years.

Подробное описание

In this study, AI model will explore and clarify features in renal tumor CT images and pathological images that are difficult to detect manually, and then correlate them with clinical outcomes, thereby improving the diagnosis and treatment process for renal tumors. Firstly, the model can accurately distinguish renal tumor subtypes and predict stage, grade, and complexity so as to svoid misdiagnosis and assist clinicians in formulating treatment plans. Secondly, by learning from surgical videos, the model can provide additional information during surgerys, such as important anatomical landmarks, location of tumors. Finally, combining radiomics and pathomics, the model can differentiate between high-risk and low-risk patients after surgery, thus providing personalized prognostic guidance.

Первичные конечные точки

• Assessing the performance of AI models by the "AUC" comprehensive assessment model [Срок оценки: From enrollment to the end of 5-years' follow up]

Вторичные конечные точки (1)

• Assessing the model's performance to predict participants' prognosis post-surgery by Kaplan-Meier Survival Analysis [Срок оценки: From enrollment to the end of 5-years' follow up]

Критерии участия

Критерии включения

• Patients with renal tumor which can be treated by surgery;
• Complete CECT within 30 days before surgery;
• Patients who fully understand this study and sign the informed consent;

Критерии исключения

• Patients with any item missing from the baseline clinical and pathological information;
• Patients who has already metastasized by the time the tumor is discovered;
• Previous treatment in any form, including surgery, targeted therapy and immunotherapy;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's H — Нанкин

Идентификаторы

NCT: NCT06714916 · 2024-SR-961

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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