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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| West China Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | This is a prospective observational study with observation only and no intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | defined as time from initiation for protocol therapy to death. | Up to 2 years |
| Metastasis free surviva | metastasis free survival defined as time from initiation of protocol therapy until the development of distal metastasis or death |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) 5.0.. | Up to 2 years |
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
Criteria:
Inclusion Criteria:
Exclusion Criteria:
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Patients with non-metastatic upper tract urothelial carcinoma receiving kidney-sparing therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwei Huang, Dr | Contact | 8613651682825 | jiweihuang@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| OTHER |
| Ruijin Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The First Affiliated Hospital of University of Science and Technology of China | OTHER |
| The Second Hospital of Anhui Medical University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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| Up to 2 years |