Actively Recruiting
Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus
Led by Peking University Third Hospital · Updated on 2026-04-14
4700
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center observational study using real-world data from 4700 patients with renal cell carcinoma (RCC), including those with venous tumor thrombus (VTT), treated at Peking University Third Hospital. The study aims to develop and validate a new prognostic prediction model for RCC patients, compare its performance against existing models, and assess whether risk-stratified treatment based on this model can improve survival outcomes using an emulated target trial approach. The study includes two main groups: patients receiving treatment aligned with the risk stratification from the new prediction model, and those whose treatment does not follow this stratification. Treatments evaluated include model-guided adjuvant therapies initiated within 12 weeks after surgery or no adjuvant treatment during follow-up before disease progression. Data is collected retrospectively from 2012 to 2025 and prospectively from 2025 to 2026, covering clinical, laboratory, imaging, pathology, and treatment information. Participants undergo follow-up visits and telephone check-ins based on European Association of Urology guidelines until events such as recurrence, death, withdrawal, or study completion. Researchers monitor survival, disease recurrence, quality of life, and healthcare resource use. The primary outcome is disease-free survival measured up to 48 months from follow-up start to recurrence, second primary cancer, death, or other events. Data quality assurance and statistical analyses are performed to evaluate model performance and treatment effects.
CONDITIONS
Brief Title
Validation of RCC Predicting Model With Emulated-target Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 60 years of age or older
- Diagnosis of primary renal cell carcinoma before or during surgery
- Received radical nephrectomy or nephron-sparing surgery
You will not qualify if you...
- Severely missing clinical information
- History of other malignant tumors
- Recurrence observed before first postoperative follow-up
- Discontinued adjuvant treatment within first two courses due to severe adverse reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks after surgery
Participants receive treatment guided by the established model, including standard adjuvant treatment initiated within 12 weeks after surgery or no adjuvant treatment, depending on their risk-stratified group assignment.
1 baseline visit at treatment initiation
Duration - Up to 48 months
Participants are followed up with telephone and outpatient visits according to risk group guidelines to monitor survival, recurrence, quality of life, and resource utilization until outcome, withdrawal, or study end.
Follow-up visits according to EAU RCC guidelines by risk group
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
J
Jiyuan Chen, master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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