Creating a diagnostic model for renal cell carcinoma with tumor thrombus 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
This study is testing a new imaging method to help doctors better understand and treat kidney cancer that has spread into the blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05589207 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a preoperative imaging diagnostic model that aligns closely with histopathological examinations for renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus. It will evaluate the impact of different layers of vascular wall invasion on long-term prognosis and identify which layers of invasion are clinically significant for treatment decisions. Patients diagnosed with RCC and IVC tumor thrombus will be included and categorized based on their vascular wall invasion status, allowing for a systematic approach to understanding the disease's progression and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with primary renal cell carcinoma with tumor thrombus who are scheduled for radical nephrectomy and thrombectomy.
Not a fit: Patients who have a history of malignant tumors or those who cannot tolerate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved preoperative diagnostic accuracy and better treatment strategies for patients with RCC and IVC tumor thrombus.
How similar studies have performed: While there is a lack of extensive studies specifically addressing this diagnostic model, the need for standardized criteria in similar conditions suggests potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiyuan Chen, MD
- Email: 1910301319@pku.edu.cn
- Phone: +86 18801430995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.