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

NCT05589207 | Recruiting

• 1 other identifier: M2022597
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Renal Cell; Tumor Thrombus; Neoplasm Invasiveness; Inferior Vena Cava Interruption

Keywords

Neoplasm Grading; Diagnostic Model; Preoperative Diagnosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.

  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

Secondary Outcomes (24)

• Clinical manifestation

  From the clinical diagnosis until the surgery, an average of 3 weeks

• Mayo classification

  The time once the preoperative imaging is assessed, up to 1 weeks.

• Primary tumor diameter

  The time once the preoperative imaging is assessed, up to 1 weeks.

• Preoperative tumor node metastasis (TNM) stage

  The time once the preoperative imaging is assessed, up to 1 weeks.

• IVC residual blood flow

  The time once the preoperative imaging is assessed, up to 1 weeks.

Study Arms (2)

Invaded Group

Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.

Diagnostic Test: Vascular wall invaded

Non-invaded group

Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.

Interventions

Vascular wall invaded DIAGNOSTIC_TEST

Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.

Invaded Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.

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;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Invasiveness

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhuo Liu, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiyuan Chen, MD

CONTACT

+86 18801430995; 1910301319@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 21, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)