Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
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StatusAccepting Candidates
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Age19 Years - N/A
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SexesAll
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网红黑料y VolunteersNo
Objective
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.
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
Details
Full study title | Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy with and without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma |
Protocol number | OCR46501 |
ClinicalTrials.gov ID | NCT06262516 |
Phase | N/A |
Eligibility
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 鈮T4, 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
Lead researcher
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Tarik Benidir, MDSurgical Oncologist (Surgical Specialist - Cancer), Urologist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.