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NCT Number: NCT06714916

Optimising Renal Tumour Management Through Artificial Intelligence Modules

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Primary outcomes

  1. Assessing the performance of AI models by the "AUC" comprehensive assessment model

    Time frame: From enrollment to the end of 5-years' follow up

    "AUC" refers to the area under the ROC (Receiver Operating Characteristic) curve, which indicates the performance of the model in predicting immunohistochemistry-related pathological information of prostate cancer after surgery, and the AUC ranges from 0-1, with the larger value indicating the better prediction effect.

Secondary outcomes

  1. Assessing the model's performance to predict participants' prognosis post-surgery by Kaplan-Meier Survival Analysis

    Time frame: From enrollment to the end of 5-years' follow up

    Kaplan-Meier Survival Analysis s a non-parametric statistic mainly used to figure out factors which indicate survival.

Study contacts

Contact information is provided by the study sponsor or research team.

Miao Haoqi, Postgraduate

CONTACT

[email protected]

+8613276636957

Shao Pengfei, Professor

CONTACT

[email protected]

+8613851925825

Sponsors and collaborators

Lead sponsor

Shao Pengfei

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Dec 4, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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