Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion

Recruiting now

Conditions studied: Carcinoma, Renal Cell, Tumor Thrombus, Neoplasm Invasiveness, Inferior Vena Cava Interruption

In brief

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.

Key facts

Study ID

NCT05589207

Run by

Peking University Third Hospital

People needed

232

Starts

2023-01-01

Expected to finish

2027-01-01

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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