UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004198
Receipt number 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 10:06:02

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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

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 or person

Institute

Japan Neuroblastoma study group

Institute

Department

Personal name



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

Value
https://center6.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