Tests lymph node removal during kidney and ureter surgery for upper urinary tract cancer
Compares surgery with or without lymph node removal in adults with upper tract urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Key facts
- Where
- Cleveland, Gainesville, and Springfield, United StatesSee the 4 sites
Where in United States
- Cleveland Clinic Glickman Urological and Kidney InstituteCleveland, United StatesTaking people
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer CenterCleveland, United StatesTaking people
- University of Florida Health Science CenterGainesville, United StatesTaking people
- Southern Illinois UniversitySpringfield, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Case Comprehensive Cancer Center
- Trial code
- NCT06262516
- Record updated
- 1 October 2026
- Original description
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:Read full original descriptionShow less
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
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.
Inclusion: 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.
Exclusion: Concomitant muscle invasive bladder cancer; 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; 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.