NCT06941038

Brief Summary

Upper urinary tract urothelial carcinoma (UTUC) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-RNU. High-risk UTUC (≥pT2, high-grade, or N+ disease) necessitates aggressive management. Intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. This study evaluates intraoperative epirubicin instillation during RNU compared to postoperative administration and no instillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

April 16, 2025

Last Update Submit

April 22, 2025

Conditions

Bladder Cancer RecurrenceIntravesical InstillationUpper Urinary Tract Carcinoma

Keywords

bladder cancerbladder cancer recurrenceintravesical instillationupper urinary tract carcinoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.

    365 days from the first instillation

Eligibility Criteria

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

tertiary care clinic

You may qualify if:

  • primary high-risk UTUC.

You may not qualify if:

  • prior bladder cancer,
  • low-risk UTUC (managed conservatively),
  • metastatic disease,
  • incomplete follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent, Ankara, Ankara 06800

Ankara, 06050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 23, 2025

Study Start

June 1, 2021

Primary Completion

April 1, 2024

Study Completion

June 20, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations

TU(1)