Urinary Bladder NeoplasmsSNUGGLENCT05742867
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
An observational study of Urinary Bladder Neoplasms, run by Bristol-Myers Squibb at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Morrisville, North Carolina, 27560
About this study
Official title: Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan
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.
- 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 1 | High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Median overall survival (years)
Measured: Up to 1 year after radical cystectomy
5-year survival rate
Defined as the percentage of patients that are alive after 5 years
Measured: Up to 1 year after radical cystectomy
Disease-free survival (DFS)
Median disease-free survival (year)
Measured: 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
Measured: 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
Measured: 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"
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 year after radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start31 May 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742867
- Sponsor's protocol ID
- CA209-6M4
- Acronym
- SNUGGLE
- Status last verified
- Jan 2025
- First submitted
- 1 Feb 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan
- ClinicalTrials.gov ID
- NCT05742867
- Acronym / sponsor ID
- SNUGGLE / CA209-6M4
- Conditions
- Urinary Bladder Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 31 May 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 24 Feb 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
Overall survival
Time frame: Up to 1 year after radical cystectomy
Median overall survival (years)
5-year survival rate
Time frame: Up to 1 year after radical cystectomy
Defined as the percentage of patients that are alive after 5 years
Disease-free survival (DFS)
Time frame: Up to 1 year after radical cystectomy
Median disease-free survival (year)
Probability of side effect-related treatment discontinuation
Time frame: Up to 1 year after radical cystectomy
Defined as the percent likelihood that a patient will stop treatment due to a side effect
Number of participants who experience treatment side effects
Time frame: Up to 1 year after radical cystectomy
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
Overall severity of side effects
Time frame: Up to 1 year after radical cystectomy
Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"
Treatment Convenience
Time frame: Up to 1 year after radical cystectomy
Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)
Treatment duration
Time frame: Up to 1 year after radical cystectomy
Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year
Hospitalization
Time frame: Up to 1 year after radical cystectomy
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
Frequency of outpatient consultations
Time frame: Up to 1 year after radical cystectomy
Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months
Annual treatment costs
Time frame: Up to 1 year after radical cystectomy
Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Bristol-Myers Squibb at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 1 year after radical cystectomy). The study lists 11 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 23 Jan 2025.