Menu
Not yet recruiting NCT07735793

A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea

— Observational Urinary Bladder Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Urinary Bladder Neoplasms. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea

Overview

The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) who have undergone radical cystectomy (surgical procedure to remove entire urinary bladder). NMIBC is a type of bladder cancer in which cancer is confined to innermost lining of the bladder and MIBC is a type of bladder cancer in which cancer has grown deep into the thick muscle of the bladder.

Primary outcome measures

  • Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC) [Time frame: Up to 12 months post RC procedure]
  • Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC [Time frame: Up to 3 years post RC procedure]
  • Cohort B: Mortality Within 30 days After RC [Time frame: Up to 30 days post RC procedure]
  • Cohort B: Mortality Within 90 days After RC [Time frame: Up to 90 days post RC procedure]
  • Cohort B: Length Of Stay (LOS) for Hospitalization for RC [Time frame: Up to 3 years post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 30 Days After RC [Time frame: Up to 30 days post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 90 Days After RC [Time frame: Up to 90 days post RC procedure]
  • Cohort B: Number of Participants with Readmission Within 12-Months After RC [Time frame: Up to 12-month post RC procedure]
  • Cohort B: Number of Hospital Visits Within 12-Months After RC [Time frame: Up to 12 months post RC procedure]
  • Cohort B: Number of Hospital Visits Within 3 Years After RC [Time frame: Up to 3 years post RC procedure]
Secondary outcome measures (12)
  • Cohort A: Percentage of Participants by Bladder Cancer Stage [Time frame: At Baseline]
  • Cohort A: Treatment Patterns: Type of Treatment [Time frame: Up to approximately 5 years]
  • Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy [Time frame: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy [Time frame: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles [Time frame: Up to approximately 5 years]
  • Cohort A: BCG Treatment Status: Total Duration of BCG Therapy [Time frame: Up to approximately 5 years]
  • Cohort B: Time from Diagnosis to RC [Time frame: Up to approximately 8 years]
  • Cohort B: Time from Last BCG to RC [Time frame: Up to approximately 8 years]
  • Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure [Time frame: Up to 12 months post RC procedure]
  • Cohort B: Total Costs from Diagnosis to RC [Time frame: Up to approximately 8 years]
  • Cohort B: Total Costs for the Period after RC [Time frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure]
  • Cohort B: Total Cost for Hospitalization for RC [Time frame: Up to approximately 8 years]

Eligibility criteria

Inclusion criteria

  • Participants newly diagnosed with bladder cancer (BC) (International statistical classification of diseases and related health problems, 10th revision \[ICD-10\] codes of malignant neoplasm of the bladder \[C67\] or carcinoma in-situ of bladder \[D090\] and cancer-specific insurance code of Korean national health insurance service \[V193\]) between September 1 2015 and August 31 2023
  • Having two outpatients or one inpatient visit anytime in the study period for BC

Exclusion criteria

  • Participants with a history of BC diagnosis or cystectomy during the pre-index period
  • Participants with prior primary malignancy (ICD-10 codes) that was under active treatment or follow-up during the pre-index period
  • Participants with evidence of metastatic disease at the index date, defined as: a. Having secondary malignancy codes (ICD-10 codes), or b. Having received systemic chemotherapy for BC within 6 months of the initial transurethral resection of the bladder tumor (TURBT)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735793 · 17000139BLC4008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗