UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059620 |
|---|---|
| Receipt number | R000068186 |
| Scientific Title | Multicenter Cohort Study of Oncological Outcomes and Prognosis for Urothelial Carcinoma Treated by Chemotherapy in Ehime Prefecture |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/02 11:51:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter Cohort Study of Oncological Outcomes and Prognosis for Urothelial Carcinoma Treated by Chemotherapy in Ehime Prefecture
Acronym
Urothelial Carcinoma Treated by Chemotherapy
Scientific Title
Multicenter Cohort Study of Oncological Outcomes and Prognosis for Urothelial Carcinoma Treated by Chemotherapy in Ehime Prefecture
Scientific Title:Acronym
Urothelial Carcinoma Treated by Chemotherapy
Region
| Japan |
Condition
Condition
Urotherial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to retrospectively analyze data from all institutions within the Ehime Prefecture Urological Society that have administered chemotherapy (anticancer drugs, immune checkpoint inhibitors, ADCs) to patients with urothelial carcinoma. The study will focus on clinical data, treatment outcomes, adverse events, and factors affecting treatment efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival (PFS) and overall survival (OS) for each treatment, and prognostic factors.
Key secondary outcomes
Objective response rate (ORR), best overall response (BOR) and disease control rate (DCR) for each treatment. Safety, including treatment-related adverse events. Furthermore, detailed data on adverse events related to avelumab will be collected. Subgroup analyses based on histologic classification (e.g., predominant urothelial carcinoma vs non-predominant or non-pure UC)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Episode 1 (Data update only): The study will include patients with unresectable or metastatic urothelial carcinoma who received chemotherapy from December 1, 2017, to June 30, 2024, at institutions within the Ehime Prefecture Urological Society.
Episode 2: Patients of unresectable or metastatic urothelial carcinoma treated with chemotherapy between July 1, 2024, and December 31, 2026.
Key exclusion criteria
As this is an observational study, no specific exclusion criteria are stipulated.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | KATSUYOSHI |
| Middle name | |
| Last name | HASHINE |
Organization
NHO Shikoku Cancer Center
Division name
Department of Urology
Zip code
791-0280
Address
160, Umemoto, Matsuyama, Ehime, Japan
TEL
089-999-1111
hashine.katsuyoshi.vc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | KATSUYOSHI |
| Middle name | |
| Last name | HASHINE |
Organization
NHO Shikoku Cancer Center
Division name
Department of Urology
Zip code
791-0280
Address
160, Umemoto, Matsuyama, Ehime, Japan
TEL
089-999-1111
Homepage URL
hashine.katsuyoshi.vc@mail.hosp.go.jp
Sponsor or person
Institute
NHO Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
NHO Shikoku Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Shikoku Cancer Center
Address
160, Umemoto, Matsuyama, Ehime, Japan
Tel
089-999-1111
hashine.katsuyoshi.vc@mail.hosp.go.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
| 2026 | Year | 01 | Month | 01 | 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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration Period: Episode2: January 1, 2026 (after ethics committee approval) to December 31, 2027.
Observation Period: Episode 2: January 1, 2026 to December 31, 2028.
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068186
