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BC RC DBNCT07735793

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

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Johnson & Johnson

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 53 words
    • Start date changed from estimate of Sep 30, 2026 to Oct 12, 2026
    • Trial arms changed: 2 → 1
    • Study sites: 0 to 1
    • Secondary endpoints: 12 to 6
    • Study title shortened, about 5 words
  2. Eligibility criteria expanded, about 5 words
    • Secondary endpoints: details revised at 1 of 12 entries
  3. Start date: Jul 27, 2026 to Sep 30, 2026v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Percentage of Participants Receiving Bacillus Calmette-Guérin (BCG) Induction and Maintenance Therapy
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Number of Participants Reporting BCG Treatment Completion
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Time Between Successive BCG Instillations
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Number of Intravesical Chemotherapy Instillations
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Duration of Intravesical Chemotherapy
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Frequency of Intravesical Chemotherapy Instillations
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Time Between Successive Intravesical Chemotherapy Instillations
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Number of Participants Requiring BCG Re-treatment
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Number of Participants Requiring Intravesical Chemotherapy
Timeframe: From the index date to death or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Time to Next Treatment
Timeframe: At 6, 9, 12, and 24 months after the index date
Time to Cystectomy
Timeframe: From the index date to radical cystectomy, death, or the data cutoff of August 31, 2025, whichever is earlier (up to 10 years)
Radical Cystectomy Incidence
Timeframe: At 12, 24, and 36 months after the index date
Metastasis-Free Survival
Timeframe: At 6, 9, 12, and 24 months after the index date
Overall Survival
Timeframe: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure

Secondary (6)

Number of Participants Requiring Repeat Transurethral Resection of Bladder Tumor (TURBT)
Number of Participants Requiring Systemic Therapy
Number of Participants Requiring Radical Cystectomy
Recurrence-Free Survival
Time to Recurrence
Show 1 moreShow less
Time to Progression

Arms and interventions

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.

Sites

1 site in 1 country

  • Sungkyunkwan University Research and Business FoundationSuwon, South Korea