NCT07304492

Brief Summary

The goal of this observational study is to learn whether the artificial intelligence method can automatically identify and diagnose renal lesions using non-contrast CT or opportunistic screening.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

December 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 26, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

December 13, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

Artificial intelligenceRenal NeoplasmsRenal CystComputer tomography

Outcome Measures

Primary Outcomes (1)

  • Building an intelligent diagnostic system for renal diseases based on CT scans.

    To construct an intelligent system for the detection of renal mass lesions and their differentiation into cysts, benign, and malignant neoplasms.

    1 year

Secondary Outcomes (1)

  • Further develop artificial intelligence model to effectively diagnose pathological types of common renal tumors.

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent an abdominal CT examination.

You may qualify if:

  • Patients who underwent an abdominal CT examination.
  • Patients with renal lesions were managed according to standard clinical pathways, which included follow-up, biopsy, or surgery.
  • Malignant lesions were pathologically confirmed; benign lesions were confirmed by either pathological diagnosis or imaging follow-up.
  • No prior treatment had been received for the renal disease.

You may not qualify if:

  • Patients refuse to undergo recommended follow-up, biopsy, or surgery, which precluded definitive diagnosis of the renal lesion.
  • Absence of complete pathological confirmation for lesions suspected to be malignant.
  • Patients have received any form of prior treatment for the renal lesion.
  • Poor image quality that hampered diagnostic evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan university Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Radiology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 26, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 26, 2025

Record last verified: 2025-10

Locations