Urinary Bladder NeoplasmsBC RC DBNCT07735793
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
An observational study of Urinary Bladder Neoplasms, run by Janssen Korea, Ltd., Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 23 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study consists of participants newly diagnosed with NMIBC/MIBC and a subset of NMIBC/MIBC participants who have undergone radical cystectomy (RC).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study 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.
- Conditions
- Urinary Bladder Neoplasms
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)
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.
Measured: Up to 12 months post RC procedure
Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC
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.
Measured: Up to 3 years post RC procedure
Cohort B: Mortality Within 30 days After RC
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Measured: Up to 30 days post RC procedure
Cohort B: Mortality Within 90 days After RC
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Measured: Up to 90 days post RC procedure
Cohort B: Length Of Stay (LOS) for Hospitalization for RC
LOS for the hospitalization for RC in participants from Cohort B will be reported.
Measured: Up to 3 years post RC procedure
Cohort B: Number of Participants with Readmission Within 30 Days After RC
Number of participants from Cohort B with readmission after RC will be reported.
Measured: Up to 30 days post RC procedure
Cohort B: Number of Participants with Readmission Within 90 Days After RC
Number of participants from Cohort B with readmission after RC will be reported.
Measured: Up to 90 days post RC procedure
Cohort B: Number of Participants with Readmission Within 12-Months After RC
Number of participants from Cohort B with readmission after RC will be reported.
Measured: Up to 12-month post RC procedure
Cohort B: Number of Hospital Visits Within 12-Months After RC
Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 12 months after RC will be reported.
Measured: Up to 12 months post RC procedure
Cohort B: Number of Hospital Visits Within 3 Years After RC
Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 3 years after RC will be reported.
Measured: Up to 3 years post RC procedure
Secondary outcomes (12)
Cohort A: Percentage of Participants by Bladder Cancer Stage
Percentage of participants from Cohort A by bladder cancer stage will be reported.
Measured: At Baseline
Cohort A: Treatment Patterns: Type of Treatment
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.
Measured: Up to approximately 5 years
Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy
Number of participants receiving intravesical chemotherapy will be reported.
Measured: Up to approximately 5 years
Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy
Percentage of participants receiving BCG induction and maintenance therapy will be reported.
Measured: Up to approximately 5 years
Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles
Number of BCG maintenance cycles will be reported.
Measured: Up to approximately 5 years
Cohort A: BCG Treatment Status: Total Duration of BCG Therapy
Total duration of BCG therapy will be reported.
Measured: Up to approximately 5 years
Cohort B: Time from Diagnosis to RC
Time from diagnosis to RC amongst participants from Cohort B will be reported.
Measured: Up to approximately 8 years
Cohort B: Time from Last BCG to RC
Time from last BCG to RC amongst participants from Cohort B will be reported.
Measured: Up to approximately 8 years
Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure
Participants with the occurrence of any post-RC complication within 12 months will be reported.
Measured: Up to 12 months post RC procedure
Cohort B: Total Costs from Diagnosis to RC
Total medical costs for the period from diagnosis to RC will be reported.
Measured: Up to approximately 8 years
Cohort B: Total Costs for the Period after RC
Total medical costs for the period after RC will be reported.
Measured: Up to 30 days, 90 days, 12 months and 3 years post-RC procedure
Cohort B: Total Cost for Hospitalization for RC
Total costs for the hospitalization for RC will be reported.
Measured: Up to approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea Ltd. Clinical Trial, Study director, Janssen Korea Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735793
- Sponsor's protocol ID
- 17000139BLC4008
- Acronym
- BC RC DB
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea
- ClinicalTrials.gov ID
- NCT07735793
- Acronym / sponsor ID
- BC RC DB / 17000139BLC4008
- Conditions
- Urinary Bladder Neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study consists of participants newly diagnosed with NMIBC/MIBC and a subset of NMIBC/MIBC participants who have undergone radical cystectomy (RC).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Cohort A: Percentage of Participants by Bladder Cancer Stage
Time frame: At Baseline
Cohort A: Treatment Patterns: Type of Treatment
Time frame: Up to approximately 5 years
Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy
Time frame: Up to approximately 5 years
Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy
Time frame: Up to approximately 5 years
Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles
Time frame: Up to approximately 5 years
Cohort A: BCG Treatment Status: Total Duration of BCG Therapy
Time frame: Up to approximately 5 years
Cohort B: Time from Diagnosis to RC
Time frame: Up to approximately 8 years
Cohort B: Time from Last BCG to RC
Time frame: Up to approximately 8 years
Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure
Time frame: Up to 12 months post RC procedure
Cohort B: Total Costs from Diagnosis to RC
Time frame: Up to approximately 8 years
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
Cohort B: Total Cost for Hospitalization for RC
Time frame: Up to approximately 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Korea Ltd. Clinical Trial study director
Janssen Korea Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.