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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004355 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | neuroblastoma | ||||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Japan Neuroblastoma Study Group |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005206 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |