UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Differential expression profiling to understand genetic regulation of kidney stone formation
Title of the study (Brief title)	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	Shuzo Hamamoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Nephro-urology
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	Shuzo Hamamoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Nagoya City University Graduate School of Medical Sciences
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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