Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 200123, China
Location status: Recruiting
NCT Number: NCT06204406
Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is <50% for pT2/T3 and <10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200123, China
Location status: Recruiting
The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
Criteria:
Inclusion criteria
Exclusion criteria
This is a prospective observational study with observation only and no intervention
Time frame: Up to 2 years
events-free survival defined as time from initiation of first protocol therapy until the first time to develop any local recurrence (local/bladder), distant metastases or any cause-related death.
Time frame: Up to 2 years
defined as time from initiation for protocol therapy to death.
Time frame: Up to 2 years
metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death
Time frame: Up to 2 years
The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0..
Contact information is provided by the study sponsor or research team.
RenJi Hospital
Other
A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07504939
Upper Tract Urothelial Carcinoma, Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Beijing, China
View Trial Details