NCT06088134

Brief Summary

This study aims to preoperatively predict DFS of patients with localised ccRCC using a deep learning prognostic model based on enhanced contrast CT images, validate it's predictive ability in multicentre data and compare it's predictive ability with traditional models.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

October 12, 2023

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • disease-free survival (DFS)

    the interval from the date of surgery to disease recurrence, all-cause mortality or the last visit

    recruitment occurred between June 2013 and March 2020

Study Arms (2)

Non-recurrence group

Recurrence group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to urology departments at participating medical centres

You may qualify if:

  • underwent partial/radical nephrectomies
  • histologically diagnosed as ccRCC
  • with complete clinical data and preoperative CT image data

You may not qualify if:

  • with incomplete clinic-pathological data
  • lack of preoperative contrast-enhanced CT images or the image quality was unsuitable for analysis
  • who received pre-surgery neoadjuvant or adjuvant therapies
  • with multiple renal tumors or/and had synchronous metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yingjie Xv

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (1)

  • Xv Y, Wei Z, Jiang Q, Zhang X, Chen Y, Xiao B, Yin S, Xia Z, Qiu M, Li Y, Tan H, Xiao M. Three-dimensional deep learning model complements existing models for preoperative disease-free survival prediction in localized clear cell renal cell carcinoma: a multicenter retrospective cohort study. Int J Surg. 2024 Nov 1;110(11):7034-7046. doi: 10.1097/JS9.0000000000001808.

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
Urology Department

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

September 1, 2022

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations