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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004198
Receipt No. R000005043
Scientific Title A retrospective study of the outcome of children with neuroblastoma after relapse. the Japan neuroblastoma study group.
Date of disclosure of the study information 2010/11/01
Last modified on 2014/09/16

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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
Last 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
1st 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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