UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study of the outcome of children with neuroblastoma after relapse. the Japan neuroblastoma study group.
Acronym	A retrospective study of the outcome of children with neuroblastoma after relapse. the Japan neuroblastoma study group.
Scientific Title	A retrospective study of the outcome of children with neuroblastoma after relapse. the Japan neuroblastoma study group.
Scientific Title:Acronym	A retrospective study of the outcome of children with neuroblastoma after relapse. the Japan neuroblastoma study group.
Region	Japan

Condition
Condition	neuroblastoma
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine novel treatment for reccurent neuroblasotma patients.
Basic objectives2	Others
Basic objectives -Others	To determine novel treatment for reccurent neuroblasotma patients. To clasyfy the prognostic factors for reccurent neuroblasotma patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of treatment and prognostic factor
Key secondary outcomes	Analysis of treatment and prognostic factor

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	Not applicable
Gender	Male and Female
Key inclusion criteria	neuroblastoma with recurrence
Key exclusion criteria	not specified
Target sample size	125

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiko Hashii
Organization	Osaka University Graduate School of Medicine
Division name	Department of Developmental Medicine,
Zip code
Address	2-2 Yamadaoka Suita city Osaka Japan
TEL	0606879-3932
Email	areken@ped.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name HASHII YOSHIKO
Organization	Osaka University Graduate School of Medicine
Division name	Department of Developmental Medicine
Zip code
Address	2-2 Yamadaoka Suita Osaka Japan
TEL	06-6879-5111
Homepage URL
Email	areken@ped.med.osaka-u.ac.jp

Sponsor
Institute	Japan Neuroblastoma study group
Institute
Department

Funding Source
Organization	Japan Neuroblastoma study group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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 11 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	2010 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 12 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information	See evaluation form

Management information
Registered date	2010 Year 09 Month 13 Day
Last modified on	2014 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005043

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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