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

NCT ID: NCT05742867

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Bladder Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy

No interventions assigned to this group

Eligibility Criteria

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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):

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Morrisville, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-6M4

Identifier Type: -

Identifier Source: org_study_id

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