A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Histopathological confirmed upper tract urothelial carcinoma;

• Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;

• Participants must be willing to attend the follow-up visits;

• Sign informed consent.

Locations
Other Locations
China
Shanghai Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jiwei Huang, Dr
jiweihuang@outlook.com
8613651682825
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 106
Treatments
Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
The enrolled patients were patients with limited-stage or locally advanced UTUC, who were classified into the following four categories according to the 2022 EAU guidelines as low-risk and high-risk: 1) low-risk patients who were willing to undergo kidney-sparing surgery directly; 2) High-risk patients, with solitary kidney, functional single kidney, bilateral tumors, and absolute kidney-sparing indications; 3) High-risk patients with renal insufficiency, or diseases that lead to renal insufficiency, have relative indications for kidney protection; 4) High-risk patients with good renal function, but a particularly strong willingness to preserve the kidney, willing to accept clinical studies and participate in kidney preservation.
Sponsors
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Shanghai Zhongshan Hospital, Xiangya Hospital of Central South University, Tianjin Medical University Second Hospital
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov

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