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Trial Title:
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
NCT ID:
NCT05742867
Condition:
Urinary Bladder Neoplasms
Conditions: Official terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
The study population is composed of 115 Japanese participants, 18 years and older, with
muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Local Institution - 0001
Address:
City:
Morrisville
Zip:
27560
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site 0001
Start date:
May 31, 2023
Completion date:
June 28, 2024
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742867
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
https://www.bmsstudyconnect.com/s/US/English/USenHome
