UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056273 |
|---|---|
| Receipt number | R000064284 |
| Scientific Title | HR-QOL of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder (MIBC) patients undergoing SOC treatment in Japan |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2024/11/25 16:09:28 |
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Basic information
Public title
HR-QOL of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder (MIBC) patients undergoing SOC treatment in Japan
Acronym
HR-QOL of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder (MIBC) patients undergoing SOC treatment in Japan
Scientific Title
HR-QOL of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder (MIBC) patients undergoing SOC treatment in Japan
Scientific Title:Acronym
HR-QOL of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder (MIBC) patients undergoing SOC treatment in Japan
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the EORTC QLQ-C30 scores, EORTC QLQ-NMIBC24/ BLM30 scores, and DCS scores among NMIBC and MIBC patients in Japan.
Basic objectives2
Others
Basic objectives -Others
To evaluate the real-world HR-QOL scores and DCS scores in various subgroups such as age, sex, and comorbidity, and potentially other relevant factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
EORTC QLQ-C30 scores, EORTC QLQ-NMIBC24/ BLM30 scores, and DCS scores
Key secondary outcomes
EORTC QLQ-C30, EORTC QLQ-NMIBC24/ BLM30, and DCS scores in subgroups
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
Each patient must satisfy the following criteria to be eligible for data collection in this study:
･Patients are male or female aged 18 years and older
･Patients have a confirmed diagnosis of NMIBC or MIBC
For NMIBC patients (either one of the following):
･A) Currently receiving or have received the last BCG therapy within the last 6 months.
･B) BCG-unresponsive and currently receiving or have received the last RC therapy within the last 6 months.
For MIBC patients (either one of the following):
･A) Have previously undergone complete RC within the last 6 months.
･B) Currently receiving or have received the last bladder preservation therapy (combination of TURBT, chemotherapy, and/or radiotherapy) within the last 6 months.
Key exclusion criteria
Potential patients who meet any of the following criteria will not be eligible for this study:
1.Patients with metastatic bladder cancer or any other concurrent cancer
2.Patients who have undergone partial RC or a combination of BCG, RC and TMT
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Janssen Pharmaceutical K.K.
Division name
Oncology Dept., Medical Affairs Div.
Zip code
101-0065
Address
3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
TEL
03-4411-7700
HHoshiy1@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, Japan
TEL
050-3640-3110
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2024 | Year | 11 | Month | 29 | 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
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as a questionnaire survey of NMIBC and MIBC patients.
Management information
Registered date
| 2024 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064284
