UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062309 |
|---|---|
| Receipt number | R000071305 |
| Scientific Title | Real-world clinical outcomes of adjuvant pembrolizumab following surgery for high-risk renal cell carcinoma: a multicenter retrospective study (SHINSHU study) |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/22 22:10:58 |
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Basic information
Public title
Real-world clinical outcomes of adjuvant pembrolizumab following surgery for high-risk renal cell carcinoma: a multicenter retrospective study (SHINSHU study)
Acronym
Real-world clinical outcomes of adjuvant pembrolizumab following surgery for high-risk renal cell carcinoma: a multicenter retrospective study (SHINSHU study)
Scientific Title
Real-world clinical outcomes of adjuvant pembrolizumab following surgery for high-risk renal cell carcinoma: a multicenter retrospective study (SHINSHU study)
Scientific Title:Acronym
SHINSHU study
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the natural course of renal cell carcinoma after surgery
Basic objectives2
Others
Basic objectives -Others
to clarefy tye role of adjuvant pembrorizumab
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease free survival
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Renal cell carcinoma patients who received surgery
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Minagawa |
Organization
Shinshu University
Division name
Urology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto city
TEL
0263372661
minagawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Minagawa |
Organization
Shinshu University
Division name
Urology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto city
TEL
0263372661
Homepage URL
minagawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Ethical bord of shinshu University
Address
3-1-1 Asahi, Matsumoto city
Tel
0263372661
minagawat@shinshu-u.ac.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 | 08 | 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
100
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This trial was conducted as a retrospective analysis for recurrence of RCC.
Management information
Registered date
| 2026 | Year | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071305
