UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of the treatment for low risk neuroblastomas with decision of surgical indications based on IDRF (Image Defined Risk Factors)
Acronym	Observational study of the treatment for low risk neuroblastomas based on IDRF
Scientific Title	Observational study of the treatment for low risk neuroblastomas with decision of surgical indications based on IDRF (Image Defined Risk Factors)
Scientific Title:Acronym	Observational study of the treatment for low risk neuroblastomas based on IDRF
Region	Japan

Condition
Condition	neuroblastoma
Classification by specialty	Hematology and clinical oncology Surgery in general Pediatrics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To observe and evaluate the incidence of adverse events such as the incidence of surgical complication, and the efficacy of the treatment for low risk neuroblastomas with decision of surgical indications based on IDRF (Image Defined Risk Factors)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	3-year progression free survival rate 3-year overall survival rate The incidence of surgical complication The incidence of adverse events
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	Not applicable
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Low risk neuroblastoma patients under 18 years of age
Key exclusion criteria	Active double cancer, pregnant or possiblly pregnant women and those during breast feeding, patients with psychologic disease or symptoms who have difficulty in receiving protocol treatment, patients with disease that may interfere with the protocol treatment
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuro Tajiri
Organization	Kyushu University Hospital
Division name	Pediatric Surgery
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL	092-542-5573
Email

Public contact
Name of contact person	1st name Middle name Last name Tatsuro Tajiri
Organization	Kyushu University Hospital
Division name	Pediatric Surgery
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL	092-642-5573
Homepage URL
Email	taji@pedsurg.med.kyushu-u.ac.jp

Sponsor
Institute	Japan Neuroblastoma Study Group
Institute
Department

Funding Source
Organization	A research grant from the Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

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	2010 Year 10 Month 21 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	Open public recruiting
Date of protocol fixation	2010 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study aims to observe and evaluate the the incidence of adverse events such as the incidence of surgical complication, and the efficacy of the treatment for low risk neuroblastomas with decision of surgical indications based on IDRF (Image Defined Risk Factors).

Management information
Registered date	2010 Year 10 Month 07 Day
Last modified on	2011 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005206

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.