NCT05589207Recruiting
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 · Last updated 21 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 232 (estimated)
- First submitted
- 15 Oct 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT05589207
What you commit to
- Study type: Observational
- Planned participants: 232
- From 1 Jan 2023 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Attached other addition operations in the surgery;
- Received neoadjuvant treatment before the surgery;
Other illness
- Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment);
Other
- Failed to receive standard nephrectomy for any reason;
- Experience serious consequences or death due to anesthesia accident during operation;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.