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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245759
• Other study ID #: TJIRB20230888
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Huazhong University of Science and Technology
• Contact: Pu Zhou, MD
• Phone: +86 27 83662379
• Email: tongjihlunli[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Non-Muscle-Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• This was a retrospective study and no patient intervention was performed
This was a retrospective study and no patient intervention was performed

Locations

Country	Name	City	State
China	Ke Chen	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time	OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients	up to 20 years
Primary	Recurrence free survival time	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.	up to 16 years