Clinical trial · Observational
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are: * To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations. * To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus; * To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrence outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model will be established.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Inferior Vena Cava Interruption | — | UNRESOLVED | — |
| Neoplasm Invasiveness | — | UNRESOLVED | — |
| Tumor Thrombus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vascular wall invaded | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Invaded Group
- description
- Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.
- interventionNames
- Diagnostic Test: Vascular wall invaded
- label
- Non-invaded group
- description
- Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of randomization until the date of lost follow-up or date of death from any cause, whichever came first, assessed up to 120 months
- description
- The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Secondary outcomes (24)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥18 years of age; * Accepted abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT and MRI before the surgery; * Diagnosis of primary renal cell carcinoma with tumor thrombus before and during the surgery; * Received radical nephrectomy and at least one kind of thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection) * Can tolerate the surgery; * Eastern Cooperative Oncology Group Performance Status Scale (ECOG-PS) 0\~2; * No previous history of malignant tumor; * Willing to return for required follow-up visits Exclusion Criteria: * Failed to receive standard nephrectomy for any reason; * Attached other addition operations in the surgery; * Received neoadjuvant treatment before the surgery; * Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment); * Experience serious consequences or death due to anesthesia accident during operation;
References
Publications (23)
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- BACKGROUNDAdams LC, Ralla B, Bender YY, Bressem K, Hamm B, Busch J, Fuller F, Makowski MR. Renal cell carcinoma with venous extension: prediction of inferior vena cava wall invasion by MRI. Cancer Imaging. 2018 May 3;18(1):17. doi: 10.1186/s40644-018-0150-z. PMID 29724245
- BACKGROUNDIngels A, Campi R, Capitanio U, Amparore D, Bertolo R, Carbonara U, Erdem S, Kara O, Klatte T, Kriegmair MC, Marchioni M, Mir MC, Ouzaid I, Pavan N, Pecoraro A, Roussel E, de la Taille A. Complementary roles of surgery and systemic treatment in clear cell renal cell carcinoma. Nat Rev Urol. 2022 Jul;19(7):391-418. doi: 10.1038/s41585-022-00592-3. Epub 2022 May 11. PMID 35546184
- BACKGROUNDLabbate C, Hatogai K, Werntz R, Stadler WM, Steinberg GD, Eggener S, Sweis RF. Complete response of renal cell carcinoma vena cava tumor thrombus to neoadjuvant immunotherapy. J Immunother Cancer. 2019 Mar 11;7(1):66. doi: 10.1186/s40425-019-0546-8. PMID 30857555
- BACKGROUNDShi T, Huang Q, Liu K, Du S, Fan Y, Yang L, Peng C, Shen D, Wang Z, Gao Y, Gu L, Niu S, Ai Q, Li H, Liu F, Li Q, Wang H, Guo A, Fu B, Yang X, Zhang X, Wang D, Wang D, Guo H, Li H, Olivero A, Fam XI, Ma X, Wang B, Zhang X. Robot-assisted Cavectomy Versus Thrombectomy for Level II Inferior Vena Cava Thrombus: Decision-making Scheme and Multi-institutional Analysis. Eur Urol. 2020 Oct;78(4):592-602. doi: 10.1016/j.eururo.2020.03.020. Epub 2020 Apr 15. PMID 32305170
- BACKGROUNDLiu Z, Zhao X, Zhang HX, Li LW, Tang SY, Wang GL, Zhang SD, Wang SM, Ma LL, Tian XJ. Surgical complexity and prognostic outcome of small volume renal cell carcinoma with high-level venous tumor thrombus and large volume renal cell carcinoma with low-level thrombus. Chin Med J (Engl). 2019 Aug 5;132(15):1780-1787. doi: 10.1097/CM9.0000000000000352.