Optimising Renal Tumour Management Through Artificial Intelligence Modules

NCT ID: NCT06714916

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Neoplasms Pathology Renal Cell Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shao Pengfei

OTHER

Sponsor Role lead

Responsible Party

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Shao Pengfei

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shao Pengfei, Professor

Role: CONTACT

+8613851925825

Miao Haoqi, Postgraduate

Role: CONTACT

+8613276636957

Facility Contacts

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Shao Pengfei, Professor

Role: primary

+8613851925825

Miao Haoqi, Postgraduate

Role: backup

+8613276636957

Other Identifiers

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2024-SR-961

Identifier Type: -

Identifier Source: org_study_id

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