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Brief Title: 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


  • Org Study ID: CASE2824
  • Secondary ID: N/A
  • NCT ID: NCT06262516
  • Sponsor: Case Comprehensive Cancer Center


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.


Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates

  • Overall Status
  • Start Date
    May 17, 2024
  • Phase
    Not Applicable
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Urothelial Carcinoma


Inclusion Criteria:
* 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 Criteria:
* Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0)

- * Presence of distant metastases

- * 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.

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Mohamed Eltemamy, MD, Adam Calaway, MD, MPH

Role: Principal Investigator, Principal Investigator

Affiliation: Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Overall Contact

Name: Mohamed Eltemamy, MD, Rebecca Campbell, MD

Phone: 216-444-5888, 216-444-1105



Facility Status Contact
Facility: University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Adam Calaway, MD, MPH

Principal Investigator
Adam Calaway, MD, MPH

Facility: Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Mohamed Eltemamy, MD