Development of AI Model for Renal Tumor Diagnosis Using CT and Lab Tests

December 30, 2024 updated by: RenJi Hospital

An Artificial Intelligence Model for Accurate Diagnosis of Renal Tumors Based on Multi-phase Contrast-enhanced CT and Laboratory Tests: A Model Development and Multi-center Evaluation Study

This multi-center retrospective study aims to develop a multimodal artificial intelligence diagnostic model using preoperative contrast-enhanced CT images and routine laboratory parameters from patients with renal tumors. The model is designed to assist clinicians in accurately predicting the pathological subtypes of renal tumors preoperatively, enabling detailed diagnoses and advancing precision medicine.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1922

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai Jiaotong University School of Medicine, Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients who underwent renal tumor resection at multiple centers, with complete preoperative imaging and laboratory data. Eligible participants include those with pathological diagnoses of clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma. Patients with incomplete imaging data, poor-quality CT images, or coexistence of multiple pathological types of renal tumors were excluded.

Description

Inclusion Criteria:

  • Underwent renal tumor resection with a complete postoperative pathological report, and the pathological diagnosis is one of the following types: clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, renal angiomyolipoma, or renal oncocytoma.
  • Complete and available four-phase contrast-enhanced CT scans prior to surgery.
  • Complete and available routine laboratory test results prior to surgery.

Exclusion Criteria:

  • Incomplete CT data or poor image quality that affects diagnostic analysis.
  • A time interval of more than three months between imaging or laboratory testing and pathological diagnosis.
  • Patients diagnosed with fat-rich renal angiomyolipoma (AML).
  • Pathological diagnosis indicating the coexistence of two or more pathological types of renal tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Training Set
Validation Set
Internal Test Set
External Test Set

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pathological report
Time Frame: From the time of surgery to the release of the postoperative pathological report (typically within 2 weeks post-surgery).
From the time of surgery to the release of the postoperative pathological report (typically within 2 weeks post-surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Fudan University
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
The Affiliated Hospital Of Southwest Medical University
Fudan University Pudong Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiagnosisModel_RenalTumor_AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available to interested research partners upon reasonable request to Wei Zhai or Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; the prerequisite for this is a data transfer agreement, approved by the legal departments of the requesting researcher and by all legal departments of the institutions that provided data for the study, and an ethics clearance.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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