Nephroureterectomy
ProcedureParticipants will undergo standard-of-care nephroureterectomy for UTUC.
NCT Number: NCT06262516
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
University of Florida Health Science Center, Gainesville, Florida, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo standard-of-care nephroureterectomy for UTUC.
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
Time frame: 2 years post-op
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
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.
Time frame: 2 years post-op
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.
Contact information is provided by the study sponsor or research team.
Mohamed Eltemamy, MD
CONTACT
Rebecca Campbell, MD
CONTACT
Case Comprehensive Cancer Center
Other
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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