About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
The study consists of participants newly diagnosed with NMIBC/MIBC and a subset of NMIBC/MIBC participants who have undergone radical cystectomy (RC).
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)
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.
Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC
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 3 years after RC (overall and by disease stage) will be reported.
Cohort B: Mortality Within 30 days After RC
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Cohort B: Mortality Within 90 days After RC
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Secondary outcomes
Cohort A: Percentage of Participants by Bladder Cancer Stage
Percentage of participants from Cohort A by bladder cancer stage will be reported.
Cohort A: Treatment Patterns: Type of Treatment
Participants receiving the different types of treatment (for example, transurethral resection of the bladder tumor \[TURBT\], Bacillus Calmette-Guerin \[BCG\], intravesical chemotherapy, radical treatment, systemic therapy, partial cystectomy, and others) during pre-RC treatment period will be reported.
Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy
Number of participants receiving intravesical chemotherapy will be reported.
Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy
Percentage of participants receiving BCG induction and maintenance therapy will be reported.
Locations
Sponsors and contacts
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