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Clinical Trials in China / NCT06204406
Recruiting Observational

Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

NCT06204406 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Observational
Started
2023-11-23
Last updated
2024-01-12

Condition(s) studied

Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Investigational drug(s) / intervention(s)

Observational

Observational: This is a prospective observational study with observation only and no intervention

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: 1. Histopathological confirmed upper tract urothelial carcinoma; 2. Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery; 3. Participants must be willing to attend the follow-up visits; 4. Sign informed consent. Exclusion Criteria: 1. Unable to undergo kidney-sparing surgery; 2. Life expectancy \< 6 months; 3. Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Renji Hospital Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06204406 on ClinicalTrials.gov ↗ ← All trials in China