Validation of RCC Predicting Model With Emulated-target Trial

NCT07117227 | Recruiting

• 2 other identifiers: RCCETTQY23064
• Study Type: observational
• Target: 4,700
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Renal Cell Carcinoma (Kidney Cancer); Renal Cell Carcinoma (RCC); Tumor Thrombus; Prognosis; Prognostic Cancer Model; Real World Study; Observational Study

Keywords

renal cell carcinoma; tumor thrombus; prognostic model; emulated-target trial

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.

  From date of follow-up until the date of (1) local or regional recurrence, (2) distant recurrence, (3) second primary cancer, or (4) death from any cause., whichever came first, assessing up to 48 months.

Study Arms (2)

model-stratified group

Patient receiving treatment in accord with stratified result of the established model.

Procedure: Model-guided adjuvant treatment

non-model-stratified group

Patient receiving treatment not in accord with stratified result of the established model.

Procedure: No adjuvant treatment

Interventions

No adjuvant treatment PROCEDURE

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

non-model-stratified group

Model-guided adjuvant treatment PROCEDURE

Initiation of standard adjuvant treatment within 12 weeks after surgery.

model-stratified group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Yongyue Wei, master

  Peking University Health Science Center

  STUDY DIRECTOR

• Shudong Zhang, master

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiyuan Chen, master

CONTACT

+086 18801430995; chenjiyuan@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)