UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058287 |
|---|---|
| Receipt number | R000066609 |
| Scientific Title | A Prospective Investigation of the Tumor Immune Microenvironment and Genomic Instability in Renal and Urothelial Cancers |
| Date of disclosure of the study information | 2025/06/26 |
| Last modified on | 2025/06/26 14:04:16 |
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Basic information
Public title
A Prospective Study on Tumor Immunogenomics in Renal and Urothelial Malignancies
Acronym
RUGI study: Renal and Urothelial cancer's Genomic instability and Immune microenvironment
Scientific Title
A Prospective Investigation of the Tumor Immune Microenvironment and Genomic Instability in Renal and Urothelial Cancers
Scientific Title:Acronym
RUGI study: Renal and Urothelial cancer's Genomic instability and Immune microenvironment
Region
| Japan |
Condition
Condition
Renal and Urothelial cancers
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the underlying mechanisms contributing to the progression of genitourinary cancers and the development of resistance to therapeutic agents.
Basic objectives2
Others
Basic objectives -Others
To investigate the involvement of immune-related factors, angiogenic and lymphangiogenic factors, cancer cell-specific molecular expressions, and genomic instability - including genetic mutations, epigenetic alterations, and microsatellite instability - in the progression and drug resistance of genitourinary cancers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
| 10 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with genitourinary cancer at our institution
Key exclusion criteria
Patients without informed consent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3825
urotanaka@keio.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3825
Homepage URL
urotanaka@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio Unieversity
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
Keio University school of Medicine
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3825
urotanaka@keio.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 | 06 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective study will enroll patients diagnosed with genitourinary cancers at Keio University Hospital. Residual tumor tissues from surgical specimens - obtained after routine pathological diagnosis - will be used for prospective evaluation of immune-related factors, angiogenic and lymphangiogenic markers, and cancer cell-specific molecular expressions by immunohistochemistry. The residual tissues will be sourced from the Department of Pathology as well as archived samples previously used in other research projects at the Cancer Center. In addition, genomic instability will be assessed prospectively using various molecular techniques, including next-generation sequencing (DNA and RNA), microarray analysis, in situ hybridization, and PCR-based methods.
Management information
Registered date
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066609
