The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients

Recruiting

• Conditions: Non-Muscle-Invasive Bladder Cancer; Bladder Cancer
• Interventions: Other: This was a retrospective study and no patient intervention was performed

• Registration Number: NCT06245759
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-08-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the U.S. National Cancer Center SEER database	This was a retrospective study and no patient intervention was performed	The Chinese NMIBC cohort includes patients from January 1996 to December 2019 at 15 institutions.
the Chinese Bladder Cancer Alliance CBCC database	This was a retrospective study and no patient intervention was performed	SEER\*Stat software (version 8.4.1.1) collected 17 registries cohort data on NMIBC patients diagnosed between 2000 and 2020.

Primary Outcome Measures

Name	Time	Method
Overall survival time	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	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.

Trial Locations

Locations (1)

Ke Chen; 🇨🇳 Wuhan, Hubei, China