UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of late renal failure evaluation by cystatin C for pediatric kidney tumor patients
Title of the study (Brief title)	Study of late renal failure evaluation by cystatin C for pediatric kidney tumor patients
Region	Japan

Condition
Condition	kidney tumor
Classification by specialty	Pediatrics Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Purpose is whether serum cystatin C can be detected at an early stage renal failure in pediatric kidney tumor patients during and after treatment
Basic objectives2	Others
Basic objectives -Others	examine the patients with renal failure after treatment of childhood renal tumor
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Whether the course of the subsequent renal failure of cases that showed abnormal rates of serum cystatin C.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who participated in the clinical trial of JWiTS study
Key exclusion criteria	Other than those above
Target sample size	50

Research contact person
Name of lead principal investigator	Hajime Hosoi
Organization	Graduate School of Medical Science Kyoto Prefectural University of Medicine
Division name	Pediatrics
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL	0752515571
Email	hhosoi@koto.kpu-m.ac.jp

Public contact
Name of contact person	Tomoko Iehara
Organization	Graduate School of Medical Science Kyoto Prefectural University of Medicine
Division name	Pediatrics
Address	Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL	0752515571
Homepage URL
Email	iehara@koto.kpu-m.ac.jp

Sponsor
Institute	JWiTS
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	the Practical Research for Innovative Cancer Control from Japan Agency for Medical Research and development, AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 09 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 11 Month 16 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	practical research

Management information
Registered date	2015 Year 06 Month 09 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020685