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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorJanssen Korea, Ltd., Korea

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1 Participants
are grouped into 2 trial groups
Group A: Cohort A: NMIBC/MIBC Cohort
Group B: Cohort B: RC cohort

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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.

Time frame
Up to approximately 5 years
3

Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy

Number of participants receiving intravesical chemotherapy will be reported.

Time frame
Up to approximately 5 years
4

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.

Time frame
Up to approximately 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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