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RecruitingNCT07735793BC RC DBUpdated Nov 9, 2026

A Real-world Study in Participants With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin Therapy in Korea

An observational study in Urinary Bladder Neoplasms, sponsored by Janssen Korea, Ltd., Korea. Recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Janssen Korea, Ltd., Korea (part of Johnson & Johnson) · Observational

Updated Nov 9, 2026Now RecruitingFirst site in South Korea+6 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study 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 high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have received Bacillus Calmette-Guérin (BCG) therapy. HR-NMIBC is a type of bladder cancer in which cancer is confined to the inner lining of the bladder and has a high risk of returning or becoming more serious. BCG therapy is a treatment administered directly into the bladder to help prevent the cancer from returning or progressing.

02

Conditions studied

  • Urinary Bladder Neoplasms
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's planned enrollment of 1 is below the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Janssen Korea, Ltd., Korea is the lead sponsor of 79 studies on the registry; 2 are open to participants now.

Browse Janssen Korea, Ltd., Korea studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 9, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study consists of participants with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who received Bacillus Calmette-Guérin (BCG) therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of bladder cancer (BC) based on International Classification of Diseases, 10th Revision (ICD-10) codes (C67 or D090) and cancer-specific insurance code V193 within the patient identification period of September 1, 2015, to August 31, 2024.
  • Two outpatient or one inpatient visit anytime during the study period for bladder cancer.
  • Received intravesical Bacillus Calmette-Guérin (BCG) following the qualifying transurethral resection of bladder tumor (TURBT). The date of first BCG instillation serves as the index date.
  • No evidence of bladder cancer diagnosis, intravesical chemotherapy, or BCG in the 5-year look-back period prior to the qualifying TURBT, to ensure an incident BC definition.

Exclusion criteria

Exclusion Criteria:

  • Evidence of disease based on confirmed diagnosis (ICD-10: C77-C80) on or before index TURBT, or within 30 days after the index TURBT.
  • Evidence of confirmed cancer diagnosis other than bladder cancer (ICD-10: C00-C76, C81-C97, excluding C67) on or before the index TURBT.
  • Evidence of systemic treatments or radical cystectomy within 30 days after index TURBT.
  • Less than 12 months of potential follow-up to the data cutoff after the index date (including patients with a claims-inactivity-based death proxy within 12 months from the index date).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1 participant (estimated)
Patient registry
No

Groups and cohorts

  • BCG-treated HR-NMIBC Cohort

    Participants with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who received intravesical Bacillus Calmette-Guérin (BCG) therapy following a qualifying transurethral resection of bladder tumor (TURBT) between September 1, 2015, and August 31, 2024, will be enrolled in the cohort. Data will be collected using the Health Insurance Review and Assessment Service (HIRA) claims database. No drug will be given as part of the study.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Receiving Bacillus Calmette-Guérin (BCG) Induction and Maintenance Therapy

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

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  2. Number of Participants Reporting BCG Treatment Completion

    The number of participants reporting completion of BCG treatment will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  3. Time Between Successive BCG Instillations

    The time between successive BCG instillations will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  4. Number of Intravesical Chemotherapy Instillations

    The number of intravesical chemotherapy instillations after the index date will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  5. Duration of Intravesical Chemotherapy

    The duration of intravesical chemotherapy after the index date will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  6. Frequency of Intravesical Chemotherapy Instillations

    The frequency of intravesical chemotherapy instillations after the index date will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  7. Time Between Successive Intravesical Chemotherapy Instillations

    The time between successive intravesical chemotherapy instillations after the index date will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  8. Number of Participants Requiring BCG Re-treatment

    The number of participants requiring BCG re-treatment following the index BCG course will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  9. Number of Participants Requiring Intravesical Chemotherapy

    The number of participants requiring intravesical chemotherapy following the index BCG course will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  10. Time to Next Treatment

    Time to next treatment is defined as the time from the index date to the date of the next localized or systemic intervention for bladder cancer.

    Time frame: At 6, 9, 12, and 24 months after the index date

  11. Time to Cystectomy

    Time to cystectomy is defined as the time from the index date to the date of radical cystectomy.

    Time frame: From the index date to radical cystectomy, death, or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  12. Radical Cystectomy Incidence

    The cumulative incidence of radical cystectomy will be estimated, with death treated as a competing risk.

    Time frame: At 12, 24, and 36 months after the index date

  13. Metastasis-Free Survival

    Metastasis-free survival is defined as the time from the index date to evidence of metastasis or death from any cause, whichever occurs first.

    Time frame: At 6, 9, 12, and 24 months after the index date

  14. Overall Survival

    Overall survival is defined as the time from the index date to death from any cause.

    Time frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure

Secondary outcomes

  1. Number of Participants Requiring Repeat Transurethral Resection of Bladder Tumor (TURBT)

    The number of participants requiring repeat transurethral resection of bladder tumor (TURBT) following the index BCG course will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  2. Number of Participants Requiring Systemic Therapy

    The number of participants requiring systemic therapy following the index BCG course will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  3. Number of Participants Requiring Radical Cystectomy

    The number of participants requiring radical cystectomy following the index BCG course will be reported.

    Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)

  4. Recurrence-Free Survival

    Recurrence-free survival is defined as the time from the index date to the first claims-based recurrence or progression proxy event or death due to any cause, whichever occurs first.

    Time frame: At 3, 6, 9, 12, and 24 months after the index date

  5. Time to Recurrence

    Time to recurrence is defined as the time from the index date to the first claims-based recurrence proxy event.

    Time frame: At 6, 9, 12, and 24 months after the index date

  6. Time to Progression

    Time to progression is defined as the time from the index date to the first claims-based progression proxy event.

    Time frame: At 6, 9, 12, and 24 months after the index date

07

Study locations

1 of 1 sites recruiting
  • Sungkyunkwan University Research and Business Foundation
    Suwon, 16419, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Data sharing details ↗ · www.jnj.com

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
1 site added — first site in South Korea
Show site
  • Sungkyunkwan University Research and Business Foundation · Suwon, South Korea
Nov 9, 2026
Start date
Sep 30, 2026→Oct 12, 2026 (actual)
Nov 9, 2026
Eligibility
Minimum age 19 Years→18 Years; Criteria largely rewritten (11 changes)
What changed in the criteria
Inclusion criteria
  • ChangedBefore 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 2023Now Confirmed diagnosis of bladder cancer (BC) based on International Classification of Diseases, 10th Revision (ICD-10) codes (C67 or D090) and cancer-specific insurance code V193 within the patient identification period of September 1, 2015, to August 31, 2024.
  • EditedHaving two outpatientsTwo outpatient or one inpatient visit anytime induring the study period for BCbladder cancer.
  • AddedReceived intravesical Bacillus Calmette-Guérin (BCG) following the qualifying transurethral resection of bladder tumor (TURBT). The date of first BCG instillation serves as the index date.
  • AddedNo evidence of bladder cancer diagnosis, intravesical chemotherapy, or BCG in the 5-year look-back period prior to the qualifying TURBT, to ensure an incident BC definition.
Exclusion criteria
  • RemovedParticipants with a history of BC diagnosis or cystectomy during the pre-index period
  • RemovedParticipants with prior primary malignancy (ICD-10 codes) that was under active treatment or follow-up during the pre-index period
  • RemovedParticipants 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)
  • AddedEvidence of metastatic disease based on confirmed diagnosis (ICD-10: C77-C80) on or before index TURBT, or within 30 days after the index TURBT.
  • AddedEvidence of confirmed cancer diagnosis other than bladder cancer (ICD-10: C00-C76, C81-C97, excluding C67) on or before the index TURBT.
  • AddedEvidence of systemic treatments or radical cystectomy within 30 days after index TURBT.
  • AddedLess than 12 months of potential follow-up to the data cutoff after the index date (including patients with a claims-inactivity-based death proxy within 12 months from the index date).
Nov 9, 2026
Interventions
Arms added: BCG-treated HR-NMIBC Cohort; arms removed: Cohort A: NMIBC/MIBC Cohort·Cohort B: RC cohort
Nov 9, 2026
Primary outcomes
14 added, 10 removed
What changed in the outcomes
  • AddedPercentage of Participants Receiving Bacillus Calmette-Guérin (BCG) Induction and Maintenance TherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Participants Reporting BCG Treatment CompletionTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedTime Between Successive BCG InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedDuration of Intravesical ChemotherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedFrequency of Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedTime Between Successive Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Participants Requiring BCG Re-treatmentTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Participants Requiring Intravesical ChemotherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedTime to Next TreatmentTime frame: At 6, 9, 12, and 24 months after the index date
  • AddedTime to CystectomyTime frame: From the index date to radical cystectomy, death, or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedRadical Cystectomy IncidenceTime frame: At 12, 24, and 36 months after the index date
  • AddedMetastasis-Free SurvivalTime frame: At 6, 9, 12, and 24 months after the index date
  • AddedOverall SurvivalTime frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure
  • RemovedCohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)Time frame: Up to 12 months post RC procedure
  • RemovedCohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RCTime frame: Up to 3 years post RC procedure
  • RemovedCohort B: Mortality Within 30 days After RCTime frame: Up to 30 days post RC procedure
  • RemovedCohort B: Mortality Within 90 days After RCTime frame: Up to 90 days post RC procedure
  • RemovedCohort B: Length Of Stay (LOS) for Hospitalization for RCTime frame: Up to 3 years post RC procedure
  • RemovedCohort B: Number of Participants with Readmission Within 30 Days After RCTime frame: Up to 30 days post RC procedure
  • RemovedCohort B: Number of Participants with Readmission Within 90 Days After RCTime frame: Up to 90 days post RC procedure
  • RemovedCohort B: Number of Participants with Readmission Within 12-Months After RCTime frame: Up to 12-month post RC procedure
  • RemovedCohort B: Number of Hospital Visits Within 12-Months After RCTime frame: Up to 12 months post RC procedure
  • RemovedCohort B: Number of Hospital Visits Within 3 Years After RCTime frame: Up to 3 years post RC procedure
Nov 9, 2026
Secondary outcomes
6 added, 12 removed
What changed in the outcomes
  • AddedNumber of Participants Requiring Repeat Transurethral Resection of Bladder Tumor (TURBT)Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Participants Requiring Systemic TherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedNumber of Participants Requiring Radical CystectomyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
  • AddedRecurrence-Free SurvivalTime frame: At 3, 6, 9, 12, and 24 months after the index date
  • AddedTime to RecurrenceTime frame: At 6, 9, 12, and 24 months after the index date
  • AddedTime to ProgressionTime frame: At 6, 9, 12, and 24 months after the index date
  • RemovedCohort A: Percentage of Participants by Bladder Cancer StageTime frame: At Baseline
  • RemovedCohort A: Treatment Patterns: Type of TreatmentTime frame: Up to approximately 5 years
  • RemovedCohort A: Treatment Pattern: Number of Participants Receiving Intravesical ChemotherapyTime frame: Up to approximately 5 years
  • RemovedCohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance TherapyTime frame: Up to approximately 5 years
  • RemovedCohort A: BCG Treatment Status: Number of BCG Maintenance CyclesTime frame: Up to approximately 5 years
  • RemovedCohort A: BCG Treatment Status: Total Duration of BCG TherapyTime frame: Up to approximately 5 years
  • RemovedCohort B: Time from Diagnosis to RCTime frame: Up to approximately 8 years
  • RemovedCohort B: Time from Last BCG to RCTime frame: Up to approximately 8 years
  • RemovedCohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC ProcedureTime frame: Up to 12 months post RC procedure
  • RemovedCohort B: Total Costs from Diagnosis to RCTime frame: Up to approximately 8 years
  • RemovedCohort B: Total Costs for the Period after RCTime frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure
  • RemovedCohort B: Total Cost for Hospitalization for RCTime frame: Up to approximately 8 years
Nov 9, 2026
Title
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea→A Real-world Study in Participants With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin Therapy in Korea
Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in South Korea
    Show site
    • Sungkyunkwan University Research and Business Foundation · Suwon, South Korea
    Start date Sep 30, 2026→Oct 12, 2026 (now actual)
    Eligibility Minimum age 19 Years→18 Years; Criteria largely rewritten (11 changes)
    What changed in the criteria
    Inclusion criteria
    • ChangedBefore 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 2023Now Confirmed diagnosis of bladder cancer (BC) based on International Classification of Diseases, 10th Revision (ICD-10) codes (C67 or D090) and cancer-specific insurance code V193 within the patient identification period of September 1, 2015, to August 31, 2024.
    • EditedHaving two outpatientsTwo outpatient or one inpatient visit anytime induring the study period for BCbladder cancer.
    • AddedReceived intravesical Bacillus Calmette-Guérin (BCG) following the qualifying transurethral resection of bladder tumor (TURBT). The date of first BCG instillation serves as the index date.
    • AddedNo evidence of bladder cancer diagnosis, intravesical chemotherapy, or BCG in the 5-year look-back period prior to the qualifying TURBT, to ensure an incident BC definition.
    Exclusion criteria
    • RemovedParticipants with a history of BC diagnosis or cystectomy during the pre-index period
    • RemovedParticipants with prior primary malignancy (ICD-10 codes) that was under active treatment or follow-up during the pre-index period
    • RemovedParticipants 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)
    • AddedEvidence of metastatic disease based on confirmed diagnosis (ICD-10: C77-C80) on or before index TURBT, or within 30 days after the index TURBT.
    • AddedEvidence of confirmed cancer diagnosis other than bladder cancer (ICD-10: C00-C76, C81-C97, excluding C67) on or before the index TURBT.
    • AddedEvidence of systemic treatments or radical cystectomy within 30 days after index TURBT.
    • AddedLess than 12 months of potential follow-up to the data cutoff after the index date (including patients with a claims-inactivity-based death proxy within 12 months from the index date).
    Primary outcomes 14 added, 10 removed
    What changed in the outcomes
    • AddedPercentage of Participants Receiving Bacillus Calmette-Guérin (BCG) Induction and Maintenance TherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Participants Reporting BCG Treatment CompletionTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedTime Between Successive BCG InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedDuration of Intravesical ChemotherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedFrequency of Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedTime Between Successive Intravesical Chemotherapy InstillationsTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Participants Requiring BCG Re-treatmentTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Participants Requiring Intravesical ChemotherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedTime to Next TreatmentTime frame: At 6, 9, 12, and 24 months after the index date
    • AddedTime to CystectomyTime frame: From the index date to radical cystectomy, death, or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedRadical Cystectomy IncidenceTime frame: At 12, 24, and 36 months after the index date
    • AddedMetastasis-Free SurvivalTime frame: At 6, 9, 12, and 24 months after the index date
    • AddedOverall SurvivalTime frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure
    • RemovedCohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)Time frame: Up to 12 months post RC procedure
    • RemovedCohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RCTime frame: Up to 3 years post RC procedure
    • RemovedCohort B: Mortality Within 30 days After RCTime frame: Up to 30 days post RC procedure
    • RemovedCohort B: Mortality Within 90 days After RCTime frame: Up to 90 days post RC procedure
    • RemovedCohort B: Length Of Stay (LOS) for Hospitalization for RCTime frame: Up to 3 years post RC procedure
    • RemovedCohort B: Number of Participants with Readmission Within 30 Days After RCTime frame: Up to 30 days post RC procedure
    • RemovedCohort B: Number of Participants with Readmission Within 90 Days After RCTime frame: Up to 90 days post RC procedure
    • RemovedCohort B: Number of Participants with Readmission Within 12-Months After RCTime frame: Up to 12-month post RC procedure
    • RemovedCohort B: Number of Hospital Visits Within 12-Months After RCTime frame: Up to 12 months post RC procedure
    • RemovedCohort B: Number of Hospital Visits Within 3 Years After RCTime frame: Up to 3 years post RC procedure
    Secondary outcomes 6 added, 12 removed
    What changed in the outcomes
    • AddedNumber of Participants Requiring Repeat Transurethral Resection of Bladder Tumor (TURBT)Time frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Participants Requiring Systemic TherapyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedNumber of Participants Requiring Radical CystectomyTime frame: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
    • AddedRecurrence-Free SurvivalTime frame: At 3, 6, 9, 12, and 24 months after the index date
    • AddedTime to RecurrenceTime frame: At 6, 9, 12, and 24 months after the index date
    • AddedTime to ProgressionTime frame: At 6, 9, 12, and 24 months after the index date
    • RemovedCohort A: Percentage of Participants by Bladder Cancer StageTime frame: At Baseline
    • RemovedCohort A: Treatment Patterns: Type of TreatmentTime frame: Up to approximately 5 years
    • RemovedCohort A: Treatment Pattern: Number of Participants Receiving Intravesical ChemotherapyTime frame: Up to approximately 5 years
    • RemovedCohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance TherapyTime frame: Up to approximately 5 years
    • RemovedCohort A: BCG Treatment Status: Number of BCG Maintenance CyclesTime frame: Up to approximately 5 years
    • RemovedCohort A: BCG Treatment Status: Total Duration of BCG TherapyTime frame: Up to approximately 5 years
    • RemovedCohort B: Time from Diagnosis to RCTime frame: Up to approximately 8 years
    • RemovedCohort B: Time from Last BCG to RCTime frame: Up to approximately 8 years
    • RemovedCohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC ProcedureTime frame: Up to 12 months post RC procedure
    • RemovedCohort B: Total Costs from Diagnosis to RCTime frame: Up to approximately 8 years
    • RemovedCohort B: Total Costs for the Period after RCTime frame: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure
    • RemovedCohort B: Total Cost for Hospitalization for RCTime frame: Up to approximately 8 years
    Interventions Arms added: BCG-treated HR-NMIBC Cohort; arms removed: Cohort A: NMIBC/MIBC Cohort·Cohort B: RC cohort
    Title A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea→A Real-world Study in Participants With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin Therapy in Korea
    + 3 other changes: verification date, oversight details and description
  2. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07735793
Lead sponsor
Janssen Korea, Ltd., Korea
Responsible party
Sponsor
First posted
Jul 30, 2026
Start date
Oct 12, 2026
Primary completion
Nov 23, 2026 (estimated)
Completion
Nov 23, 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Korea Ltd. Clinical Trial
study director · Janssen Korea Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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