NCT06559046

Brief Summary

This study aims to establish an effective deep learning model to extract relevant information about renal tumors and kidneys from computed tomography (CT) images and predict the pathological grades of clear cell renal cell carcinoma (ccRCC). Retrospective data were collected from 483 ccRCC patients across three medical centers. Arterial phase and portal venous phase CT images from the dataset were segmented for renal tumors and kidneys. Three convolutional neural networks (CNNs) were employed to extract features from the regions of interest (ROI) in the CT images across multiple dimensions including 3D, 2.5D, and 2D. Least absolute shrinkage and selection (LASSO) regression was used for feature selection. The models were evaluated using receiver operating characteristic (ROC) curves and decision curve analysis (DCA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

5.5 years

First QC Date

August 12, 2024

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • predict the pathological grades of clear cell renal cell carcinoma (ccRCC)

    AUC curve

    2019-2024

  • predict the pathological grades of clear cell renal cell carcinoma (ccRCC)

    DCA curve

    2019-2024

Study Arms (2)

High grade

Low grade

Eligibility Criteria

Age30 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study recruited three cohorts of patients with pathologically diagnosed ccRCC, including a total of 483 patients who underwent nephrectomy or partial nephrectomy

You may qualify if:

  • Patients with a single kidney tumor have complete imaging and clinical data
  • Contrast-enhanced CT scan within 30 days before surgery
  • No treatment was performed before CT examination

You may not qualify if:

  • Patients with tumor recurrence
  • Obvious artifacts on CT images
  • The tumor is cystic
  • Multiple cysts on the affected kidney affect the delineation of renal parenchyma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua,Zhejiang, China

Jinhua, Zhejiang, 321000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 19, 2024

Study Start

January 1, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations