Renal Cell Carcinoma (Kidney Cancer)RCCETTNCT07117227
Validation of RCC Predicting Model With Emulated-target Trial
An observational study of Renal Cell Carcinoma (Kidney Cancer) and Renal Cell Carcinoma (RCC), run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Tumor Thrombus
- What is being tested?
- Model-guided adjuvant treatment and No adjuvant treatment
- Type of treatment
- Surgery or procedure
- How many people
- 4,700 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Aug 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.
Who may be able to join
- Adults ≥18 years of age;
- Diagnosis of primary renal cell carcinoma before and during the surgery;
- Received radical nephrectomy/nephron-sparing surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jiyuan Chen, master, +086 18801430995, chenjiyuan@pku.edu.cn
About this study
Official title: Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus
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 .
Read the detailed description
- Study Design and Technical Approach: This is a single-center, observational study utilizing real-world data (RWD) to achieve three primary objectives within a renal cell carcinoma (RCC) cohort, specifically focusing on patients with venous tumor thrombus (VTT):
- Objective 1 (Model Comparison): Compare the performance (discrimination, calibration, stability) of the newly developed prediction model against existing published RCC prediction models within the overall cohort and the VTT subgroup.
- Objective 2 (Causal Evaluation via ETT): Employ an Emulated Target Trial (ETT) framework to evaluate the causal impact of risk-stratified treatment guided by the prediction model on survival and health economic outcomes, compared to non-stratified treatment.
- Study Population and Data Source:
- Source: Peking University Third Hospital, Urology Department.
- Cohort: A bidirectional cohort comprising:
- Retrospective component: ~4000 RCC patients treated between January 2012 and June 2025.
- Prospective component: All eligible RCC patients treated between Dec 2025 and Dec 2026 (target total N=4700, including ~446 VTT patients).
- Inclusion Criteria: (1) Age 18-80 years; (2) Clinical diagnosis of RCC; (3) Underwent radical/partial nephrectomy.
- Exclusion Criteria: (1) Severe missing clinical information; (2) Distant metastasis at baseline; (3) History of other malignancies.
- Data Collection: Comprehensive candidate variables include demographics, lab results, imaging, treatment details (surgery, systemic therapy - neoadjuvant/adjuvant), pathology (including VTT level), and follow-up data.
- Core Methodologies:
- Missing Data: Assessed for patterns. Addressed primarily via Multiple Imputation. Sensitivity analyses will evaluate the impact of missing data assumptions.
- Outliers: Identified through data review; verified against source; excluded if confirmed erroneous.
- Emulated Target Trial (ETT):
- Objective: Estimate the effect of adhering to risk-stratified treatment (based on the model's High/Intermediate/Low risk groups) versus non-adherence.
- "Treatment" Definition: SHAP analysis will identify key features defining risk groups and inform optimal treatment strategies per group. Adherence is determined by comparing actual treatment received to the predicted risk group's recommended strategy (e.g., type/extent of surgery, use of neoadjuvant/adjuvant systemic therapy/radiotherapy).
- Group Assignment: Non-random, based on actual treatment:
- Intervention Group (Adherent): Patients whose received treatment aligned with their predicted risk stratum.
- Control Group (Non-Adherent): Patients whose received treatment did not align with their predicted risk stratum.
- Baseline: Defined as the time of first meeting eligibility criteria (also considered treatment assignment time for ETT).
- Causal Inference \& Confounding Control: Uses cloning-censoring-weighting methods to emulate randomization. Directed Acyclic Graphs (DAGs) will identify key confounders for adjustment. Intention-To-Treat (ITT) principle is the primary analysis; Per-Protocol (PP) is secondary.
- Follow-up: Starts at baseline. Includes telephone and outpatient visits. Frequency based on EAU RCC guidelines by risk group. Continues until outcome (death, recurrence), withdrawal, or study end. Captures survival, recurrence, QoL, resource utilization/costs.
- Outcomes:
- Primary: Overall Survival (OS).
- Secondary: Model performance.
- Statistical Analysis Plan:
- Descriptive Statistics: Mean, SD, median, min, max, Q1, Q3 for continuous variables; counts and percentages for categorical variables.
- Model Performance: C-statistic (AUC), calibration plots, Brier score, net reclassification improvement (NRI), integrated discrimination improvement (IDI) for comparing prediction models.
- ETT Analysis: Weighted survival analysis (e.g., weighted Kaplan-Meier, weighted Cox regression) for OS.
- Subgroup Analyses: (1) VTT presence and level; (2) Type of non-adherence (under-treatment vs. over-treatment); (3) Predicted risk group.
- Sensitivity Analyses: For (1) missing data imputation methods, model specifications, definition of adherence, follow-up duration, censoring assumptions. (2) different methods of risk group division based on predicting results for grading and nomogram models. (3) whether participants received neo-adjuvant therapy.
- Registry Procedures and Quality Assurance:
- Source Data \& Management: Primary source data is paper-based (medical records, lab reports, questionnaires, CRFs). Strict procedures for secure storage (fire/water protection), handling, and archival of source documents and certified copies are implemented.
- Data Validation Checks: Electronic data entry will incorporate predefined range and consistency checks (e.g., valid dates, plausible lab values, logical relationships between fields) to minimize entry errors.
- Source Data Verification (SDV): A subset of records will undergo source data verification comparing the entered registry data against the original source documents (medical charts, CRFs) to assess accuracy and completeness. The extent (%)/method (targeted vs. random) will be detailed in the monitoring plan.
- Data Dictionary: A comprehensive data dictionary will define all collected variables, including: variable name, source (e.g., pathology report, lab system), definition, coding (e.g., MedDRA for AEs, ICD-10 for diagnoses), format (numeric, categorical, date), units, allowable values/ranges, and handling rules for missing/special values.
- Standard Operating Procedures (SOPs): Detailed SOPs will govern all critical processes: patient identification/screening, informed consent (adhering strictly to described principles), data collection/extraction, source documentation, data entry/management, coding (AEs, medications), SDV, query management, adverse event reporting, statistical analysis, data security/privacy, and audit processes. Training on SOPs is mandatory for all study personnel.
- Quality Assurance Plan: Includes protocol/SOP adherence monitoring, regular data quality reviews (completeness, accuracy checks), SDV as above, and readiness for on-site auditing by the sponsor/institution or regulatory bodies. A process for handling protocol deviations is established.
- Sample Size Justification: Based on historical data (HR~0.65 for adjuvant therapy effect in advanced RCC), log-rank calculations determined a simulated RCT would require ~256 events. Considering the ETT design (requiring sufficient sample size for weighting and subgroup analyses) and the center's patient volume/outcome rates, a total sample size of 4700 patients is targeted to ensure adequate power for the primary ETT survival analyses within the study timeframe.
- Plan for Missing Data: The primary strategy is Multiple Imputation by Chained Equations (MICE) , assuming data is Missing At Random (MAR). Sensitivity analyses will explore the Missing Not At Random (MNAR) scenario and complete case analysis to assess robustness. Patterns of missingness will be thoroughly investigated and reported.
- Conditions
- Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Tumor Thrombus, Prognosis, Prognostic Cancer Model, Real World Study
- Being tested
- Model-guided adjuvant treatment, No adjuvant treatment
- Keywords
- renal cell carcinoma, tumor thrombus, prognostic model, emulated-target trial
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-guided adjuvant treatmentProcedure or surgery
Initiation of standard adjuvant treatment within 12 weeks after surgery.
No adjuvant treatmentProcedure or surgery
No initiation of adjuvant ICIs, radiotherapy, or targeted therapy at any point during follow-up prior to disease progression.
| Study group | Role | What they receive |
|---|---|---|
| model-stratified group | Patient receiving treatment in accord with stratified result of the established model. Receives: Procedure: Model-guided adjuvant treatment | |
| non-model-stratified group | Patient receiving treatment not in accord with stratified result of the established model. Receives: Procedure: No adjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,700 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongyue Wei, master, Study director, Peking University Health Science CenterShudong Zhang, master, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117227
- Sponsor's protocol ID
- RCCETT
- Other IDs
- QY23064
- Acronym
- RCCETT
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Concerns about re-identifying participants from de-identified datasets
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus
- ClinicalTrials.gov ID
- NCT07117227
- Acronym / sponsor ID
- RCCETT / RCCETT
- Conditions
- Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), Tumor Thrombus, Prognosis, Prognostic Cancer Model, Real World Study
- Keywords
- renal cell carcinoma, tumor thrombus, prognostic model, emulated-target trial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,700 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
- Study Design and Technical Approach: This is a single-center, observational study utilizing real-world data (RWD) to achieve three primary objectives within a renal cell carcinoma (RCC) cohort, specifically focusing on patients with venous tumor thrombus (VTT):
- Objective 1 (Model Comparison): Compare the performance (discrimination, calibration, stability) of the newly developed prediction model against existing published RCC prediction models within the overall cohort and the VTT subgroup.
- Objective 2 (Causal Evaluation via ETT): Employ an Emulated Target Trial (ETT) framework to evaluate the causal impact of risk-stratified treatment guided by the prediction model on survival and health economic outcomes, compared to non-stratified treatment.
- Study Population and Data Source:
- Source: Peking University Third Hospital, Urology Department.
- Cohort: A bidirectional cohort comprising:
- Retrospective component: ~4000 RCC patients treated between January 2012 and June 2025.
- Prospective component: All eligible RCC patients treated between Dec 2025 and Dec 2026 (target total N=4700, including ~446 VTT patients).
- Inclusion Criteria: (1) Age 18-80 years; (2) Clinical diagnosis of RCC; (3) Underwent radical/partial nephrectomy.
- Exclusion Criteria: (1) Severe missing clinical information; (2) Distant metastasis at baseline; (3) History of other malignancies.
- Data Collection: Comprehensive candidate variables include demographics, lab results, imaging, treatment details (surgery, systemic therapy - neoadjuvant/adjuvant), pathology (including VTT level), and follow-up data.
- Core Methodologies:
- Missing Data: Assessed for patterns. Addressed primarily via Multiple Imputation. Sensitivity analyses will evaluate the impact of missing data assumptions.
- Outliers: Identified through data review; verified against source; excluded if confirmed erroneous.
- Emulated Target Trial (ETT):
- Objective: Estimate the effect of adhering to risk-stratified treatment (based on the model's High/Intermediate/Low risk groups) versus non-adherence.
- "Treatment" Definition: SHAP analysis will identify key features defining risk groups and inform optimal treatment strategies per group. Adherence is determined by comparing actual treatment received to the predicted risk group's recommended strategy (e.g., type/extent of surgery, use of neoadjuvant/adjuvant systemic therapy/radiotherapy).
- Group Assignment: Non-random, based on actual treatment:
- Intervention Group (Adherent): Patients whose received treatment aligned with their predicted risk stratum.
- Control Group (Non-Adherent): Patients whose received treatment did not align with their predicted risk stratum.
- Baseline: Defined as the time of first meeting eligibility criteria (also considered treatment assignment time for ETT).
- Causal Inference \& Confounding Control: Uses cloning-censoring-weighting methods to emulate randomization. Directed Acyclic Graphs (DAGs) will identify key confounders for adjustment. Intention-To-Treat (ITT) principle is the primary analysis; Per-Protocol (PP) is secondary.
- Follow-up: Starts at baseline. Includes telephone and outpatient visits. Frequency based on EAU RCC guidelines by risk group. Continues until outcome (death, recurrence), withdrawal, or study end. Captures survival, recurrence, QoL, resource utilization/costs.
- Outcomes:
- Primary: Overall Survival (OS).
- Secondary: Model performance.
- Statistical Analysis Plan:
- Descriptive Statistics: Mean, SD, median, min, max, Q1, Q3 for continuous variables; counts and percentages for categorical variables.
- Model Performance: C-statistic (AUC), calibration plots, Brier score, net reclassification improvement (NRI), integrated discrimination improvement (IDI) for comparing prediction models.
- ETT Analysis: Weighted survival analysis (e.g., weighted Kaplan-Meier, weighted Cox regression) for OS.
- Subgroup Analyses: (1) VTT presence and level; (2) Type of non-adherence (under-treatment vs. over-treatment); (3) Predicted risk group.
- Sensitivity Analyses: For (1) missing data imputation methods, model specifications, definition of adherence, follow-up duration, censoring assumptions. (2) different methods of risk group division based on predicting results for grading and nomogram models. (3) whether participants received neo-adjuvant therapy.
- Registry Procedures and Quality Assurance:
- Source Data \& Management: Primary source data is paper-based (medical records, lab reports, questionnaires, CRFs). Strict procedures for secure storage (fire/water protection), handling, and archival of source documents and certified copies are implemented.
- Data Validation Checks: Electronic data entry will incorporate predefined range and consistency checks (e.g., valid dates, plausible lab values, logical relationships between fields) to minimize entry errors.
- Source Data Verification (SDV): A subset of records will undergo source data verification comparing the entered registry data against the original source documents (medical charts, CRFs) to assess accuracy and completeness. The extent (%)/method (targeted vs. random) will be detailed in the monitoring plan.
- Data Dictionary: A comprehensive data dictionary will define all collected variables, including: variable name, source (e.g., pathology report, lab system), definition, coding (e.g., MedDRA for AEs, ICD-10 for diagnoses), format (numeric, categorical, date), units, allowable values/ranges, and handling rules for missing/special values.
- Standard Operating Procedures (SOPs): Detailed SOPs will govern all critical processes: patient identification/screening, informed consent (adhering strictly to described principles), data collection/extraction, source documentation, data entry/management, coding (AEs, medications), SDV, query management, adverse event reporting, statistical analysis, data security/privacy, and audit processes. Training on SOPs is mandatory for all study personnel.
- Quality Assurance Plan: Includes protocol/SOP adherence monitoring, regular data quality reviews (completeness, accuracy checks), SDV as above, and readiness for on-site auditing by the sponsor/institution or regulatory bodies. A process for handling protocol deviations is established.
- Sample Size Justification: Based on historical data (HR~0.65 for adjuvant therapy effect in advanced RCC), log-rank calculations determined a simulated RCT would require ~256 events. Considering the ETT design (requiring sufficient sample size for weighting and subgroup analyses) and the center's patient volume/outcome rates, a total sample size of 4700 patients is targeted to ensure adequate power for the primary ETT survival analyses within the study timeframe.
- Plan for Missing Data: The primary strategy is Multiple Imputation by Chained Equations (MICE) , assuming data is Missing At Random (MAR). Sensitivity analyses will explore the Missing Not At Random (MNAR) scenario and complete case analysis to assess robustness. Patterns of missingness will be thoroughly investigated and reported.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| model-stratified group | – | Procedure: Model-guided adjuvant treatmentPatient receiving treatment in accord with stratified result of the established model. |
| non-model-stratified group | – | Procedure: No adjuvant treatmentPatient receiving treatment not in accord with stratified result of the established model. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.
Key inclusion criteria (3 listed)
- Adults ≥18 years of age;
- Diagnosis of primary renal cell carcinoma before and during the surgery;
- Received radical nephrectomy/nephron-sparing surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model-guided adjuvant treatmentInitiation of standard adjuvant treatment within 12 weeks after surgery. | Procedure or surgery | model-stratified group |
| No adjuvant treatmentNo initiation of adjuvant ICIs, radiotherapy, or targeted therapy at any point during follow-up prior to disease progression. | Procedure or surgery | non-model-stratified group |
Primary outcome
Disease-free Survival
Time frame: 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.
The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. Concerns about re-identifying participants from de-identified datasets
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongyue Wei, master study director
Peking University Health Science Center
Shudong Zhang, master principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma (Kidney Cancer) and Renal Cell Carcinoma (RCC), run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyuan Chen, master (+086 18801430995, chenjiyuan@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.