Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Age: 18Years +
All Genders
ID05589207
Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion
Led by Peking University Third Hospital · Updated on 2023-02-21
232
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to create a preoperative imaging diagnostic model that closely matches the results of histopathological examinations for patients with renal cell carcinoma (RCC) that has tumor thrombus invading the inferior vena cava (IVC) vascular wall. The study also seeks to develop an accurate and systematic pathological grading standard for IVC vascular wall invasion. It will explore how different layers of vascular wall invasion affect long-term prognosis and clinical treatment decisions in RCC with IVC tumor thrombus. The study includes patients diagnosed with primary RCC with IVC tumor thrombus who undergo radical nephrectomy and at least one form of IVC thrombectomy. Participants are divided into two groups based on pathological examination results: those with IVC vascular wall invasion (invaded group) and those without (non-invaded group). The study will analyze imaging tests such as abdominal ultrasound, contrast-enhanced ultrasonography, CT, and MRI to identify features of vascular wall invasion and establish a reliable preoperative diagnostic model aligned with pathological findings. Participants will be followed for three years to assess outcomes including local and distant recurrence, overall survival, and recurrence-free survival. Researchers will collect data from preoperative imaging, surgical details, pathological specimens, and postoperative recovery. Multiple clinical and imaging assessments will be conducted before surgery, with long-term monitoring of tumor metastasis and patient health status. This comprehensive follow-up aims to inform better preoperative treatment strategies and surgical planning for RCC patients with IVC tumor thrombus.
CONDITIONS
Brief Title
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Have had abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT, and MRI before surgery
- Diagnosed with primary renal cell carcinoma with tumor thrombus before and during surgery
- Received radical nephrectomy and at least one type of thrombectomy including IVC incision or resection
- Able to tolerate surgery
- Eastern Cooperative Oncology Group Performance Status Scale (ECOG-PS) score of 0 to 2
- No previous history of malignant tumor
- Willing to return for required follow-up visits
You will not qualify if you...
- Unable to receive standard nephrectomy for any reason
- Underwent additional operations during surgery
- Received neoadjuvant treatment before surgery
- Have conditions that may affect treatment outcome such as active tuberculosis, autoimmune disease, or oral glucocorticoid use
- Experienced serious complications or death due to anesthesia accident during operation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo preoperative imaging including abdominal ultrasound, contrast-enhanced ultrasonography, CT, and MRI to assess tumor thrombus and vascular wall invasion.
1 to 2 visits depending on imaging assessments
Surgery and Immediate Post-operative Care
Duration - Approximately 10 days
Participants receive radical nephrectomy and thrombectomy with pathological examination of tumor thrombus and vascular wall specimens.
1 hospital stay for surgery and immediate postoperative care
Post-operative Follow-up
Duration - Up to 3 years
Participants are followed up to monitor clinical outcomes including recurrence, survival, and complications after surgery.
Periodic visits for follow-up assessments over 3 years
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
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Research Team
J
Jiyuan Chen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Michael Lardas, Fiona Stewart, Duncan Scrimgeour...
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Bernd Wagner, Jean-Jacques Patard, Arnaud Méjean...
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Zhuo Liu, Liwei Li, Peng Hong...
https://pubmed.ncbi.nlm.nih.gov/33083491