UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059518 |
|---|---|
| Receipt number | R000067876 |
| Scientific Title | Elucidation of the pathophysiology of various renal and urinary tract diseases through immunohistochemical analysis of exfoliated cells in urine. |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/23 15:09:09 |
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Basic information
Public title
Elucidation of the pathophysiology of various renal and urinary tract diseases through immunohistochemical analysis of exfoliated cells in urine.
Acronym
Elucidation of the pathophysiology of various renal and urinary tract diseases through immunohistochemical analysis of exfoliated cells in urine.
Scientific Title
Elucidation of the pathophysiology of various renal and urinary tract diseases through immunohistochemical analysis of exfoliated cells in urine.
Scientific Title:Acronym
Elucidation of the pathophysiology of various renal and urinary tract diseases through immunohistochemical analysis of exfoliated cells in urine.
Region
| Japan |
Condition
Condition
Fabry disease and renal and urological diseases
Classification by specialty
| Medicine in general | Nephrology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-invasive immunohistochemical analysis of exfoliated urinary cells enables early diagnosis and treatment of renal and urological diseases, thereby helping to reduce healthcare costs.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The establishment of a clinically meaningful diagnostic approach enables early detection, diagnosis, and treatment of nephrological and urological disorders, thereby contributing to the reduction of new dialysis initiations and overall healthcare expenditures.
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
| 2 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were suspected of having glomerulonephritis, diabetic nephropathy, or malignant tumors of the renal or urinary tract during outpatient visits at collaborating or partner research institutions, and who provided informed consent to participate in the study.
Key exclusion criteria
Patients whose remaining sample volume is insufficient for the measurements required in this study, or who are otherwise deemed unsuitable for participation by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Niigata University of Health and Welfar
Division name
Department of Clinical Engineerring, Faculty of Medical Technology
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
025-257-4474
takashi-yokoyama@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | TAKASHI |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Niigata University of Health and Welfar
Division name
Department of Clinical Engineerring, Faculty of Medical Technology
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
025-257-4474
Homepage URL
takashi-yokoyama@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfar
Institute
Department
Personal name
TAKASHI YOKOYAMA
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfar
Address
1398 Shimamicho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
0252574474
takashi-yokoyama@nuhw.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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Potential Burdens, Risks, or Disadvantages for Participants
Participation in this study involves the use of routine examination data only, and therefore will not affect the content of medical care provided to the participants. Accordingly, there are no direct disadvantages associated with participating in this study.
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067876
