A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea | NCT07735793

NCT07735793

Overview

NCT ID: NCT07735793
Lead Sponsor: Janssen Korea, Ltd., KoreaINDUSTRY
Official Title: Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea
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
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Jul 27, 2026Estimated
Primary Completion Date: Nov 23, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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)

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Study ContactContact
Participate-In-This-Study1@its.jnj.com844-434-4210

Similar Studies

Participant Group/Arms

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.