UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study for examine the clinical feature and the incidence of neuroblastoma with opsoclonus-myoclonus syndrome
Title of the study (Brief title)	Retrospective study for neuroblastoma with opsoclonus-myoclonus syndrome
Region	Japan

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

Objectives
Narrative objectives1	Purpose is examination the clinical feature and the incidence of neuroblastoma with opsoclonus-myoclonus syndrome.
Basic objectives2	Others
Basic objectives -Others	Purpose is make the guidelines for the OMS
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms disappearance date, complications, tumor recurrence
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	neuroblstoma with opsoclonus-myoclonus syndrome
Key exclusion criteria	except for neuroblastoma
Target sample size

Research contact person
Name of lead principal investigator	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
Email	iehara@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	Japan neuroblastoma study group
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	Practical Research for Innovative Cancer Control from Japan Agency for Medical Research and development, AMED
Organization
Division
Category of Funding Organization
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	Recruiting
Date of protocol fixation	2015 Year 04 Month 03 Day
Anticipated trial start date	2015 Year 06 Month 20 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	examine the clinical feutre and the incidence of neuroblastoma with opsoclonus-myoclonus syndrome

Management information
Registered date	2015 Year 06 Month 09 Day
Last modified on	2016 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020684