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Recruitment status Terminated
Unique ID issued by UMIN UMIN000013672
Receipt No. R000015953
Scientific Title Clinical trial of 13-cis-retinoic acid for children with high-risk neuroblastoma
Date of disclosure of the study information 2014/05/01
Last modified on 2019/03/14

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Basic information
Public title Clinical trial of 13-cis-retinoic acid for children with high-risk neuroblastoma
Acronym Clinical trial of 13-cis-retinoic acid for children with high-risk neuroblastoma
Scientific Title Clinical trial of 13-cis-retinoic acid for children with high-risk neuroblastoma
Scientific Title:Acronym Clinical trial of 13-cis-retinoic acid for children with high-risk neuroblastoma
Region
Japan

Condition
Condition high-risk neuroblastoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the long-term outcome of high-risk neuroblastoma patients who receive maintenance therapy with 13-cis-retinoic acid (cis-RA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The long-term outcome of high-risk neuroblastoma patients
Key secondary outcomes Recurrence of neuroblastoma
The safety of 13-cis RA

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Roaccutane 100mg/m2 internal use for 6 months.
Total amount of Roaccutane is 18000mg/m2.
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
0 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria High-risk neuroblastoma
Key exclusion criteria The patient whom the doctor judged to be unsuitable for this clinical trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosei nishimura
Organization Kanazawa university
Division name pediatrics
Zip code
Address 13-1 Takara-machi,Kanazawa,Ishikawa
TEL 076-265-2313
Email pedialib@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Maeba
Organization Kanazawa university
Division name Pediatrics
Zip code
Address 13-1 Takara-machi,Kanazawa,Ishikawa
TEL 076-265-2313
Homepage URL
Email pedialib@med.kanazawa-u.ac.jp

Sponsor
Institute Department of pediatrics, Kanazawa university
Institute
Department

Funding Source
Organization Department of pediatrics, Kanazawa university
Organization
Division
Category of Funding Organization
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 金沢大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 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 Terminated
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
2014 Year 05 Month 01 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2018 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 08 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015953

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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