Actively Recruiting
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Led by Case Comprehensive Cancer Center · Updated on 2025-09-05
94
Participants Needed
4
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults > 18 years
- Diagnosis of UTUC confirmed by upper tract biopsy (low or high grade)
- Planned nephroureterectomy by urologic surgeon
- Disease stage ≤ cT4, N0M0 with complete TNM staging before surgery
- No muscle-invasive bladder cancer
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Enlarged lymph nodes suspicious for metastases requiring lymph node dissection (> cN0)
- Presence of distant metastases
- Muscle-invasive bladder cancer
- Reduced general condition or life-threatening disease
- Psychiatric disorder preventing understanding of consent
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University of Florida Health Science Center
Gainesville, Florida, United States, 32209
Actively Recruiting
2
Southern Illinois University
Springfield, Illinois, United States, 62702
Actively Recruiting
3
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
4
Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
M
Mohamed Eltemamy, MD
CONTACT
R
Rebecca Campbell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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