Urinary Bladder Neoplasms
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort B: Number of Hospital Visits Within 12-Months After RC | Up to 12 months post RC procedure | Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 12 months after RC will be reported. |
| Cohort B: Number of Hospital Visits Within 3 Years After RC | Up to 3 years post RC procedure | Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 3 years after RC will be reported. |
| Cohort B: Mortality Within 90 days After RC | Up to 90 days post RC procedure | Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported. |
| Cohort B: Length Of Stay (LOS) for Hospitalization for RC | Up to 3 years post RC procedure | LOS for the hospitalization for RC in participants from Cohort B will be reported. |
| Cohort B: Number of Participants with Readmission Within 30 Days After RC | Up to 30 days post RC procedure | Number of participants from Cohort B with readmission after RC will be reported. |
| Cohort B: Number of Participants with Readmission Within 90 Days After RC | Up to 90 days post RC procedure | Number of participants from Cohort B with readmission after RC will be reported. |
| Cohort B: Number of Participants with Readmission Within 12-Months After RC | Up to 12-month post RC procedure | Number of participants from Cohort B with readmission after RC will be reported. |
| Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC) | Up to 12 months post RC procedure | 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 | Up to 3 years post RC procedure | 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 | Up to 30 days post RC procedure | Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure | Up to 12 months post RC procedure | Participants with the occurrence of any post-RC complication within 12 months will be reported. |
| Cohort B: Total Costs from Diagnosis to RC | Up to approximately 8 years | Total medical costs for the period from diagnosis to RC will be reported. |
| Cohort B: Total Costs for the Period after RC | Up to 30 days, 90 days, 12 months and 3 years post-RC procedure | Total medical costs for the period after RC will be reported. |
| Cohort B: Total Cost for Hospitalization for RC | Up to approximately 8 years | Total costs for the hospitalization for RC will be reported. |
| Cohort A: Percentage of Participants by Bladder Cancer Stage | At Baseline | Percentage of participants from Cohort A by bladder cancer stage will be reported. |
| Cohort A: Treatment Patterns: Type of Treatment | Up to approximately 5 years | 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 | Up to approximately 5 years | Number of participants receiving intravesical chemotherapy will be reported. |
| Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy | Up to approximately 5 years | Percentage of participants receiving BCG induction and maintenance therapy will be reported. |
| Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles | Up to approximately 5 years | Number of BCG maintenance cycles will be reported. |
| Cohort A: BCG Treatment Status: Total Duration of BCG Therapy | Up to approximately 5 years | Total duration of BCG therapy will be reported. |
| Cohort B: Time from Diagnosis to RC | Up to approximately 8 years | Time from diagnosis to RC amongst participants from Cohort B will be reported. |
| Cohort B: Time from Last BCG to RC | Up to approximately 8 years | Time from last BCG to RC amongst participants from Cohort B will be reported. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Korea Ltd. Clinical Trial
Janssen Korea Ltd.
Outcome results
None listed