Clinical trial · Observational
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: NMIBC/MIBC Cohort
- description
- Participants newly diagnosed with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) between September 1, 2015, and August 31, 2017 will be enrolled in Cohort A. Data will be collected using the health insurance review \& assessment (HIRA) claim database. No drug will be given as a part of the study.
- label
- Cohort B: RC cohort
- description
- Participants from a subset of Cohort A, who have undergone radical cystectomy (RC) will be enrolled into Cohort B. Data will be collected using the HIRA claim database. No drug will be given as a part of the study.
Primary outcomes (10)
- measure
- Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)
- timeFrame
- Up to 12 months post RC procedure
- description
- Number of participants in Cohort B reporting post-operative complications (including hemorrhage/bleeding, cardiac, respiratory, gastrointestinal, genitourinary, wound and hernia, thrombosis/embolic, infection and sepsis, renal failure, metabolic disturbances, dehydration, failure to thrive, malnutrition, neurologic, psychiatric conditions, and miscellaneous and surgical) within 12 months after RC (overall and by disease stage) will be reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available