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

NCT07735793 | Not Yet Recruiting

• 1 other identifier: 17000139BLC4008
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 3 years post RC procedure

Secondary Outcomes (12)

• Cohort A: Percentage of Participants by Bladder Cancer Stage

  At Baseline

• Cohort A: Treatment Patterns: Type of Treatment

  Up to approximately 5 years

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

  Up to approximately 5 years

• Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy

  Up to approximately 5 years

• Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles

  Up to approximately 5 years

Study Arms (2)

Cohort A: NMIBC/MIBC Cohort

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.

Cohort B: RC cohort

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study consists of participants newly diagnosed with NMIBC/MIBC and a subset of NMIBC/MIBC participants who have undergone radical cystectomy (RC).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Korea Ltd. Clinical Trial

  Janssen Korea Ltd.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share