Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262516
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-06
Brief Title:
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None