Validation of RCC Predicting Model With Emulated-target Trial

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years of age;

Diagnosis of primary renal cell carcinoma before and during the surgery;

Received radical nephrectomy/nephron-sparing surgery.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Model-guided adjuvant treatment

    Procedure/Surgery

    Initiation of standard adjuvant treatment within 12 weeks after surgery.

  • No adjuvant treatment

    Procedure/Surgery

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

Treatment groups

4,700 Participants
are divided into 2 treatment groups
Group A: model-stratified group1 intervention
Group B: non-model-stratified group1 intervention

Trial outcomes

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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