Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus Wi… (NCT05589207) | Clinical Trial Compass
RecruitingNot Applicable
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
China232 participantsStarted 2023-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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