A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

Urinary Bladder Neoplasms Clinical Trial

— SNUGGLE  

Official title:

Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742867
• Other study ID #: CA209-6M4
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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):
• ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
• pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
• Must not have received any treatment related to MIBC after radical cystectomy

Exclusion Criteria:

• Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
• Confirmed diagnosis of other primary cancers at the time of obtaining consent
• Current participation in a MIBC clinical trial

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Local Institution - 0001	Morrisville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Median overall survival (years)	Up to 1 year after radical cystectomy
Primary	5-year survival rate	Defined as the percentage of patients that are alive after 5 years	Up to 1 year after radical cystectomy
Primary	Disease-free survival (DFS)	Median disease-free survival (year)	Up to 1 year after radical cystectomy
Primary	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
Primary	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
Primary	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
Primary	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)	Up to 1 year after radical cystectomy
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form