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

NCT06204406 | Recruiting

• 1 other identifier: LY2023-081-B
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Keywords

kidney-sparing therapy; upper tract urothelial carcinoma

Outcome Measures

Primary Outcomes (1)

• Two-year events-free survival rate

  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.

  Up to 2 years

Secondary Outcomes (2)

• Overall survival

  Up to 2 years

• Metastasis free surviva

  Up to 2 years

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Up to 2 years

Study Arms (1)

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.

Other: Observational

Interventions

Observational OTHER

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

Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy

You may qualify if:

• 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.

You may not qualify if:

• Unable to undergo kidney-sparing surgery;
• Life expectancy \< 6 months;
• Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• West China Hospital: collaborator
• Ruijin Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Jiwei Huang, Dr

CONTACT

8613651682825; jiweihuang@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: January 12, 2024
• Study Start: November 23, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)