NCT06204406Recruiting
Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
A Multicenter, Prospective, Observational Clinical Study to Evaluate the Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
Source: ClinicalTrials.gov · Last updated 12 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 106 (estimated)
- First submitted
- 26 Nov 2023
- Start date
- 23 Nov 2023
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- RenJi Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06204406
What you commit to
- Study type: Observational
- Planned participants: 106
- From 23 Nov 2023 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to undergo kidney-sparing surgery;
- Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
Other
- Life expectancy \< 6 months;
Who the study is looking for
- 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.
Criteria the registry did not label
- Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No
- Criteria:
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.