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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026711
Receipt No. 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

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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
Email 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
Email hamamo10@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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