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NCT Number: NCT07735793

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)

    Time frame: 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.

  2. Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC

    Time frame: 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.

  3. Cohort B: Mortality Within 30 days After RC

    Time frame: Up to 30 days post RC procedure

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

  4. Cohort B: Mortality Within 90 days After RC

    Time frame: Up to 90 days post RC procedure

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

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

    Time frame: Up to 3 years post RC procedure

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

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

    Time frame: Up to 30 days post RC procedure

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

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

    Time frame: Up to 90 days post RC procedure

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

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

    Time frame: Up to 12-month post RC procedure

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

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Cohort A: Percentage of Participants by Bladder Cancer Stage

    Time frame: At Baseline

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

  2. Cohort A: Treatment Patterns: Type of Treatment

    Time frame: 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.

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

    Time frame: Up to approximately 5 years

    Number of participants receiving intravesical chemotherapy will be reported.

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

    Time frame: Up to approximately 5 years

    Percentage of participants receiving BCG induction and maintenance therapy will be reported.

  5. Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles

    Time frame: Up to approximately 5 years

    Number of BCG maintenance cycles will be reported.

  6. Cohort A: BCG Treatment Status: Total Duration of BCG Therapy

    Time frame: Up to approximately 5 years

    Total duration of BCG therapy will be reported.

  7. Cohort B: Time from Diagnosis to RC

    Time frame: Up to approximately 8 years

    Time from diagnosis to RC amongst participants from Cohort B will be reported.

  8. Cohort B: Time from Last BCG to RC

    Time frame: Up to approximately 8 years

    Time from last BCG to RC amongst participants from Cohort B will be reported.

  9. Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure

    Time frame: Up to 12 months post RC procedure

    Participants with the occurrence of any post-RC complication within 12 months will be reported.

  10. Cohort B: Total Costs from Diagnosis to RC

    Time frame: Up to approximately 8 years

    Total medical costs for the period from diagnosis to RC will be reported.

  11. Cohort B: Total Costs for the Period after RC

    Time frame: 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.

  12. Cohort B: Total Cost for Hospitalization for RC

    Time frame: Up to approximately 8 years

    Total costs for the hospitalization for RC will be reported.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea

Acronym: BC RC DB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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