UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059686 |
|---|---|
| Receipt number | R000068272 |
| Scientific Title | Treatment Preferences of Patients with Non-Muscle Invasive Bladder Cancer in Japan: A Discrete Choice Experiment |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 17:19:18 |
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Basic information
Public title
Treatment Preference Study of Patients with Non-Muscle Invasive Bladder Cancer in Japan
Acronym
NMIBC-PPSS
Scientific Title
Treatment Preferences of Patients with Non-Muscle Invasive Bladder Cancer in Japan: A Discrete Choice Experiment
Scientific Title:Acronym
NMIBC-PPSS
Region
| Japan |
Condition
Condition
high-risk non-muscle-invasive bladder cancer (HR-NMIBC)
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantify patients' preferences for attributes of investigational ICI agents used in combination with BCG as alternatives to the SOC, BCG alone, for treating patients with HR-NMIBC in Japan.
Basic objectives2
Others
Basic objectives -Others
Treatment Preference; Preference weight (PW) and the relative importance (RI)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Identification of the most valued treatment attributes by HR-NMIBC patients, (2) Insights into demographic and clinical factors influencing treatment preferences.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must meet all of the following inclusion criteria to be included in the study:
1. Patients who reside in Japan and speak/read Japanese
2. Patients aged more than 18 years
3. Patients with self-reported HR-NMIBC
4. Patients who are willing and able to provide informed consent
5. Interview only: Patients who are able to participate in a video interview
6. Patient survey only: Patients who are able to access and complete an online survey
Key exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
1. Patient survey only: Patients who participated in the interview survey
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Sasaki |
Organization
Pfizer Japan Inc.
Division name
Oncology Medical Affairs, Dept. of Medical
Zip code
151-8589
Address
Shinjuku Bunka Quint Bldg, 3-22-7, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-5309-7000
katsuhiro.sasaki@pfizer.com
Public contact
Name of contact person
| 1st name | Miyu |
| Middle name | |
| Last name | Okamura |
Organization
Syneos Health Japan K.K.
Division name
Real World Research
Zip code
100-7012
Address
12F, JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6733-9690
Homepage URL
miyu.okamura@syneoshealth.com
Sponsor or person
Institute
Pfizer Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation
Address
1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
Tel
03-5287-5070
rinri@phrf.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: The study consists of two phases,two sets of a questionnaire development as Phase1 and a webbased patient survey as Phase2.
Recruitment of participants: Potential participants will be identified through the patient panel and the physician panel. Recruitment efforts will include direct invitations via email and screening questionnaires distributed through secure platforms. Eligibility will be confirmed through screening procedures based on participants' self-reported responses. (From Nov to Dec in 2025 for Phase1 and from Mar to Jul in 2026 for Phase2)
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068272
