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

N/ANot Yet RecruitingNCT07735793

Janssen Korea, Ltd., Korea1 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Bladder Neoplasms

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

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.

Time frame: Up to 12 months post RC procedure

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.

Time frame: Up to 3 years post RC procedure

Cohort B: Mortality Within 30 days After RC

Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.

Time frame: Up to 30 days post RC procedure

Cohort B: Mortality Within 90 days After RC

Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.

Time frame: Up to 90 days post RC procedure

Cohort B: Length Of Stay (LOS) for Hospitalization for RC

LOS for the hospitalization for RC in participants from Cohort B will be reported.

Time frame: Up to 3 years post RC procedure

Cohort B: Number of Participants with Readmission Within 30 Days After RC

Number of participants from Cohort B with readmission after RC will be reported.

Time frame: Up to 30 days post RC procedure

Cohort B: Number of Participants with Readmission Within 90 Days After RC

Number of participants from Cohort B with readmission after RC will be reported.

Time frame: Up to 90 days post RC procedure

Cohort B: Number of Participants with Readmission Within 12-Months After RC

Number of participants from Cohort B with readmission after RC will be reported.

Time frame: Up to 12-month post RC procedure

Cohort B: Number of Hospital Visits Within 12-Months After RC

Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 12 months after RC will be reported.

Time frame: Up to 12 months post RC procedure

Cohort B: Number of Hospital Visits Within 3 Years After RC

Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 3 years after RC will be reported.

Time frame: Up to 3 years post RC procedure

Secondary Outcomes

Cohort A: Percentage of Participants by Bladder Cancer Stage

Percentage of participants from Cohort A by bladder cancer stage will be reported.

Time frame: At Baseline

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.