Real-world look at high-risk non-muscle-invasive bladder cancer after BCG in Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes outcomes and overall well-being of patients with high-risk non-muscle-invasive bladder cancer who previously received intravesical BCG therapy. It uses real-world data to understand treatment patterns, resource use, and health status after BCG. Eligibility focuses on adults with incident bladder cancer diagnosed between 2015 and 2024, who had documented BCG treatment following TURBT and no prior bladder cancer or related therapies in the preceding five years. Exclusion includes metastatic disease or other active cancers. The study is sponsored by Janssen Korea and conducted at Sungkyunkwan University Foundation in Suwon, Korea.

Why it matters

Who can join: the full rules

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:

* Evidence of metastatic 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).

Where it's running

• Sungkyunkwan University Research and Business Foundation
  Suwon, South Korea Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.