UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026711 |
|---|---|
| Receipt number | R000030664 |
| Scientific Title | Differential expression profiling to understand genetic regulation of kidney stone formation |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/03/26 21:27:58 |
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Basic information
Public title
Differential expression profiling to understand genetic regulation of kidney stone formation
Acronym
Differential expression profiling of kidney stone formation
Scientific Title
Differential expression profiling to understand genetic regulation of kidney stone formation
Scientific Title:Acronym
Differential expression profiling of kidney stone formation
Region
| Japan | North America |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish the future molecular targeted therapy for kidney stone, we investigated the gene expression profile in Randall's plaque sections from human papillary tissues and studied the controlling factors for the development of RP by microarray and immunohistochemical analysis.
Basic objectives2
Others
Basic objectives -Others
Investigation of the gene expression profile
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene profiling of Randall's Plaque tissue in CaOx stone formers compared to norma tissue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Randall's Plaque tissue in stone formers
Interventions/Control_2
normal tissue in stone formers
Interventions/Control_3
normal tissue in idiopathic renal bleeding patients
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) idiopathic CaOx stone and CaP stone patients who will be performed retrograde intrarenal surgery (RIRS)
2) idiopathic renal bleeding patients who will be performed retrograde intrarenal surgery (RIRS)
3) PS<=1
4) patients who was obtained informed consent
Key exclusion criteria
1) patients suspicious of malignant disease
2) patients with high grade fever because of UTI
3) Hydeonephrosis>= grade 2 (Ellenfogen classification)
4) patients who can not be performed general anaesthesia
5) uncontrolled DM
6) Serum creatinine >1.5 mg/dl
7) AST or ALT >100
8) Patients with coagulation disorder
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
Address
1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL
052-853-8266
hamamo10@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuzo Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nagoya City University Graduate School of Medical Sciences
Zip code
Address
1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL
052-853-8266
Homepage URL
hamamo10@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese society for the promotion science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Urology at UCSF
Name of secondary funder(s)
Takeda science foundation
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | 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
| 2017 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030664
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
