Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Participants will undergo nephroureterectomy for UTUC and will receive LND.

Participants will undergo nephroureterectomy for UTUC and will not receive LND.

Participants will undergo standard-of-care nephroureterectomy for UTUC.

Nephroureterectomy

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Lymph Node Dissection

Mohamed Eltemamy, MD

Rebecca Campbell, MD

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

This study is designed as a 1:1 two armed randomized-controlled trial.

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

This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.

Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.

Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.

Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.

Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.

Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.

T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND.

T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma	NCT06262516	Urothelial Carc...	Nephroureterect... Lymph Node Diss...	19 Years -	Case Comprehensive Cancer Center
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma	NCT06262516	Urothelial Carc...	Nephroureterect... Lymph Node Diss...	19 Years -	Case Comprehensive Cancer Center

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