UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004355 |
|---|---|
| Receipt number | R000005206 |
| Scientific Title | Observational study of the treatment for low risk neuroblastomas with decision of surgical indications based on IDRF (Image Defined Risk Factors) |
| Date of disclosure of the study information | 2010/10/21 |
| Last modified on | 2011/04/07 09:14:06 |
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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
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
taji@pedsurg.med.kyushu-u.ac.jp
Sponsor or person
Institute
Japan Neuroblastoma Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
