RecruitingNCT07117227

Validation of RCC Predicting Model With Emulated-target Trial

Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus


Sponsor

Peking University Third Hospital

Enrollment

4,700 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This single-center study utilizes real-world data (2012-2024) from 4700 renal cell carcinoma (RCC) patients at Peking University Third Hospital to: (1) Develop and validate a prognostic prediction model specifically for RCC patients, including those with venous tumor thrombus (VTT); (2) Compare the performance of this new model against existing RCC prediction models in both the overall RCC cohort and the VTT subgroup; (3) Employ an emulated target trial (ETT) methodology to evaluate whether risk-stratified treatment based on the prediction model (grouping patients as high/medium/low risk) improves survival outcomes .


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Adults ≥18 years of age;
  • Diagnosis of primary renal cell carcinoma before and during the surgery;
  • Received radical nephrectomy/nephron-sparing surgery.

Exclusion Criteria4

  • 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.

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Interventions

PROCEDUREModel-guided adjuvant treatment

Initiation of standard adjuvant treatment within 12 weeks after surgery.

PROCEDURENo adjuvant treatment

No initiation of adjuvant ICIs, radiotherapy, or targeted therapy at any point during follow-up prior to disease progression.


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT07117227


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