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临床试验/NCT06245759
NCT06245759招募中不适用

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 120,000 人开始时间: 2023年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120,000
试验地点
1
主要终点
Overall survival time

研究概览

简要总结

Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.

详细描述

Background Most bladder cancers are non-muscle invasive bladder cancer (NMIBC), and transurethral resection of bladder tumors (TURBT) is the standard treatment. However, postoperative recurrence poses a challenge, and the influence of bladder tumor location on prognosis is unclear. This study aims to investigate how tumor location affects NMIBC patients' prognosis undergoing TURBT, and seeks optimal surgical approaches.

Methods Conducted a multicenter study, including Chinese NMIBC data from 15 hospitals (1996-2019) and SEER 17 registries (2000-2020). Analyzed patients initially diagnosed with NMIBC undergoing TURBT or partial cystectomy, excluding cases with lost follow-up or missing data. Studied overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS). Employed Kaplan-Meier, Cox regression, and propensity score matching to explore the association between tumor location and prognosis. Stratified populations were analyzed to minimize bias.

Findings This study, involving 118,477 NMIBC patients, highlighted tumor location as a crucial factor impacting post-TURBT prognosis. Anterior wall and dome tumors independently predicted adverse outcomes in both cohorts. For anterior wall tumors, Chinese cohort showed OS HR 4.35, p < 0.0001; RFS HR 2.21, p < 0.0001; SEER OS HR 1.10, p = 0.0001; DSS HR 1.13, p = 0.0183. Dome tumors displayed similar trends (Chinese NMIBC cohort OS HR 7.91, p < 0.0001; RFS HR 2.12, p < 0.0001; SEER OS HR 1.05, p = 0.0087; DSS HR 1.14, p = 0.0006). Partial cystectomy significantly improved dome tumor survival compared to standard TURBT (p < 0.01).

Interpretation This study reveal that NMIBC tumor location significantly influences TURBT treatment outcomes. Specifically, tumors in the anterior wall and bladder dome have worse post-TURBT prognosis. Compared to TURBT, partial cystectomy improves prognosis for bladder dome tumors. This study guides personalized treatment and prognosis management for NMIBC patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent TURBT or partial cystectomy.
  • The follow-up data of the patients were complete.
  • The tumor location information were complete.

排除标准

  • Patients with unknown survival time or missing tumor location information were excluded.
  • Exclude patients with missing pathological results.
  • Exclude patients who have had TURBT before.

结局指标

主要结局

Overall survival time

时间窗: up to 20 years

OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients

Recurrence free survival time

时间窗: up to 16 years

Recurrence-free survival (RFS) is the time from the time a patient achieved complete response after antineoplastic therapy to the time of recurrence or the end of follow-up. The longer the relapse-free survival time, the better the efficacy of anti-tumor therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilong Liu

Director

Huazhong University of Science and Technology

研究点 (1)

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