RECRUITING

Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Conditions

Urothelial Carcinoma Nephroureterectomy Kidney and ureter Upper Tract Urothelial Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Quick Facts

Study Start:2024-05-17

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06262516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mohamed Eltemamy, MD

CONTACT

216-444-5888

Eltemam@ccf.org

Rebecca Campbell, MD

CONTACT

216-444-1105

CAMPBER7@ccf.org

Principal Investigator

Mohamed Eltemamy, MD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center

Adam Calaway, MD, MPH

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

United States

Cleveland Clinic Glickman Urological and Kidney Institute

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Mohamed Eltemamy, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
Adam Calaway, MD, MPH, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-17

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2024-05-17

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

Nephroureterectomy
Kidney and ureter
Upper Tract Urothelial Cell Carcinoma

Additional Relevant MeSH Terms

Urothelial Carcinoma