NCT06993779

Brief Summary

Upper Tract Urothelial Carcinoma (UTUC), characterized by its anatomical complexity and often aggressive clinical behavior, presents substantial difficulties in accurate diagnosis and reliable prognostication. The stratification of postoperative survival utilizing radiomics features derived from imaging and characteristics from whole slide images could prove instrumental in guiding therapeutic decisions to enhance patient outcomes. In this research, our objective is to construct a deep learning-based prognostic-stratification system designed for the automated prediction of overall and cancer-specific survival in individuals diagnosed with UTUC.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

January 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 20, 2025

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    the time from the date of surgery to death from any cause or the date of last contact (censored observation) at the date of data cut-off.

    up to 10 years

Secondary Outcomes (1)

  • Recurrence free survival

    up to 10 years

Study Arms (1)

AI-UTUC

Patients with Upper Tract Urothelial Carcinoma (UTUC) who underwent radical nephroureterectomy (RNU)

Other: Deep learning system for prognostication prediction in upper tract urothelial carcinoma

Interventions

develop and validate a deep learning system for prognostication prediction in upper tract urothelial carcinoma based on CT radiomics and whole slide images.

AI-UTUC

Eligibility Criteria

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

We included patients who had surgery only or who had neoadjuvant chemotherapy before surgery. We excluded patients with a postoperative diagnosis of non-urothelial carcinoma.

You may qualify if:

  • Patients with Upper Tract Urothelial Carcinoma (UTUC) who had radical nephroureterectomy (RNU).
  • Contrast-enhanced CT scan (e.g., CT urography) less than two weeks before surgery.
  • Complete CT image data and clinical data.
  • Complete whole slide image data.

You may not qualify if:

  • Patients with a postoperative diagnosis of non-urothelial carcinoma.
  • Poor quality of CT images and/or whole slide image data.
  • Incomplete clinical and follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, The First Affiliated Hospital of Chongqing Medical University, chongqing, chongqing 400016 Recruiting

Chongqing, 400016, China

Location

Study Design

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

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

November 1, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The datasets analyzed during the current study are not publicly available due to the privacy of patients but are available from the corresponding author on reasonable request.

Locations