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โ† Trials
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Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

RecruitingNAAges 19 Years - anyAllCase Comprehensive Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰คcT4, 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
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What it tests

  • Nephroureterectomy
  • Lymph Node Dissection
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Where

4 sites
University of Florida Health Science Center
Gainesville, United States
Southern Illinois University
Springfield, United States
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, United States
Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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