NCT06262516Recruiting
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are: * To determine oncologic outcomes, specifically 2-year recurrence-free survival * To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival * To determine time to recurrence and recurrence patterns * To determine use of adjuvant therapies * To determine perioperative complications Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 17 May 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Bladder cancer
- NCT number
- NCT06262516
What you commit to
- Study type: Interventional
- Planned participants: 94
- From 17 May 2024 to the primary completion date, 1 Jan 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant muscle invasive bladder cancer
Other illness
- The participant is in a reduced general condition or has a life-threatening disease.
- The participant has a psychiatric disorder that precludes them from understanding the consent process.
Other
- Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (\>cN0)
- Presence of distant metastases
- The patient is pregnant
Who the study is looking for
- Adults \> 18 years
- Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
- Planned for nephroureterectomy by their urologic surgeon
- Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
- No concomitant muscle-invasive bladder cancer
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Glickman Urological and Kidney Institute Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Florida Health Science Center Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Southern Illinois University Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.