A kidney cancer prediction model to guide treatment decisions, including for patients with tumor thrombus
Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus
This project will test whether a new prediction model can guide treatment choices to improve survival for adults with renal cell carcinoma, including those with venous tumor thrombus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4700 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07117227 on ClinicalTrials.gov |
What this trial studies
This is a single-center observational analysis using real-world data from about 4,700 RCC patients treated at Peking University Third Hospital from 2012–2026. Researchers will develop and validate a prognostic model for RCC (including a venous tumor thrombus subgroup), compare its discrimination and calibration against existing published models, and examine model stability. An emulated target trial framework will be used to compare outcomes of risk-stratified adjuvant treatment (high/medium/low risk) versus non-stratified treatment, with survival and health-economic endpoints. The cohort includes adults 18–80 years who underwent radical or partial nephrectomy and excludes patients with distant metastasis at baseline or severely incomplete records.
Who should consider this trial
Good fit: Adults aged 18–80 with primary renal cell carcinoma who underwent radical or nephron-sparing nephrectomy and have complete clinical data are ideal candidates.
Not a fit: Patients with distant metastasis at baseline, a history of other malignancies, severely missing clinical records, or who discontinue adjuvant treatment early are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the model could help doctors personalize adjuvant treatment so higher-risk patients get more aggressive therapy while lower-risk patients avoid unnecessary treatment.
How similar studies have performed: Several published RCC prognostic models exist and have shown variable predictive performance, but applying an emulated target trial to test model-guided treatment in RCC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years of age; * Diagnosis of primary renal cell carcinoma before and during the surgery; * Received radical nephrectomy/nephron-sparing surgery. Exclusion Criteria: * Subjects with severely missing clinical information; * History of other malignant tumors. * Recurrence observed before first postoperative follow-up. * Discontinue the adjuvant treatment within in the first two course because of severe adverse react.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shudong Zhang, master — Peking University Third Hospital
- Study coordinator: Jiyuan Chen, master
- Email: chenjiyuan@pku.edu.cn
- Phone: +086 18801430995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.