NCT06262516 Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
| NCT ID | NCT06262516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2024-05-17 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. * The patient is pregnant
Contact & Investigator
Mohamed Eltemamy, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06262516 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06262516 currently recruiting?
Yes, NCT06262516 is actively recruiting participants. Contact the research team at Eltemam@ccf.org for enrollment information.
Where is the NCT06262516 trial being conducted?
This trial is being conducted at Gainesville, United States, Springfield, United States, Cleveland, United States, Cleveland, United States.
Who is sponsoring the NCT06262516 clinical trial?
NCT06262516 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Mohamed Eltemamy, MD at Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center. The trial plans to enroll 94 participants.