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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Median overall survival (years) | Up to 1 year after radical cystectomy |
| 5-year survival rate | Defined as the percentage of patients that are alive after 5 years | Up to 1 year after radical cystectomy |
| Disease-free survival (DFS) | Median disease-free survival (year) | 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 | 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 | 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" | 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) |
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Inclusion Criteria:
Must reside in Japan and able to speak/read Japanese for the interview/survey
Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):
Must not have received any treatment related to MIBC after radical cystectomy
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Morrisville | North Carolina | 27560 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 | 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 | 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 | 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 | Up to 1 year after radical cystectomy |
| BMS Clinical Trial Patient Recruiting | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |