UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060775 |
|---|---|
| Receipt number | R000069491 |
| Scientific Title | Nova-sTAR PIONEER-JP-Panel Interview of ONcology practice with Experience of TAR-200 in Japan |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/24 15:18:50 |
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Basic information
Public title
Nova-sTAR PIONEER-JP-Panel Interview of ONcology practice with Experience of TAR-200 in Japan
Acronym
Nova-sTAR PIONEER-JP
Scientific Title
Nova-sTAR PIONEER-JP-Panel Interview of ONcology practice with Experience of TAR-200 in Japan
Scientific Title:Acronym
Nova-sTAR PIONEER-JP
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe early experiences regarding TAR-200 insertion, removal, and patient care from physicians with experience treating patients with TAR-200 in clinical trials. Based on the findings, the study aims to identify clinical best practices, barriers, and future care models to support the appropriate use of TAR-200.
Basic objectives2
Others
Basic objectives -Others
Qualitative research on physician experiences
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative data describing physicians' experiences with TAR-200 insertion, removal, and patient care (e.g., AE monitoring, treatment schedule, patient education, patient follow-up).
Key secondary outcomes
Qualitative data identifying barriers, proposed solutions, opportunities for improvement in medical adoption of TAR-200, and anticipated evolution of the health care model.
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
Physicians who meet the following criteria:
1.Had experience of treatment with TAR-200 in HR-NMIBC and/or MIBC patients in clinical trials.
2.Provided consent to participate in the interview and/or roundtable discussion.
Key exclusion criteria
None
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mako |
| Middle name | |
| Last name | Nakaya |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Div.
Zip code
101-0065
Address
3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065
TEL
03-4411-7700
mnakaya7@its.jnj.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Onishi |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-5294-8393
Homepage URL
onishi.46072@intage.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
INTAGE Healthcare Inc., PLAMED Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 02 | Month | 27 | 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
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069491
