NCT06204406 Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy
| NCT ID | NCT06204406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 106 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 106 participants in total. It began in 2023-11-23 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06204406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06204406 currently recruiting?
Yes, NCT06204406 is actively recruiting participants. Contact the research team at jiweihuang@outlook.com for enrollment information.
Where is the NCT06204406 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06204406 clinical trial?
NCT06204406 is sponsored by RenJi Hospital. The trial plans to enroll 106 participants.
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