Clinical trial NCT06204406: Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Official title: A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Keywords: kidney-sparing therapy
upper tract urothelial carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Tianjin Medical University Second Hospital
name: Xiangya Hospital of Central South University
name: West China Hospital
name: Ruijin Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital of University of Science and Technology of China
name: The Second Hospital of Anhui Medical University
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2024-01-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy

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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Two-year events-free survival rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years
measure: Metastasis free surviva
timeFrame: Up to 2 years
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
Study officials:
References: