An observational study in Urinary Bladder Neoplasms, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Bristol-Myers Squibb · Observational
The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's enrollment of 115 is below the median of 200 across 123 observational studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.
Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):
Exclusion Criteria:
High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy
Overall survival
Median overall survival (years)
Time frame: Up to 1 year after radical cystectomy
5-year survival rate
Defined as the percentage of patients that are alive after 5 years
Time frame: Up to 1 year after radical cystectomy
Disease-free survival (DFS)
Median disease-free survival (year)
Time frame: Up to 1 year after radical cystectomy
Probability of side effect-related treatment discontinuation
Defined as the percent likelihood that a patient will stop treatment due to a side effect
Time frame: Up to 1 year after radical cystectomy
Number of participants who experience treatment side effects
Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment
Time frame: Up to 1 year after radical cystectomy
Overall severity of side effects
Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"
Time frame: Up to 1 year after radical cystectomy
Treatment Convenience
Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)
Time frame: Up to 1 year after radical cystectomy
Treatment duration
Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year
Time frame: Up to 1 year after radical cystectomy
Hospitalization
Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week
Time frame: Up to 1 year after radical cystectomy
Frequency of outpatient consultations
Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months
Time frame: Up to 1 year after radical cystectomy
Annual treatment costs
Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY
Time frame: Up to 1 year after radical cystectomy
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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