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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035689
Receipt No. R000040653
Scientific Title Multi-center prospective observational study verifying the feasibility of molecular genetic testing for pediatric patients with acute lymphoblastic leukemia. : JCCG ALL-18 study.
Date of disclosure of the study information 2019/02/01
Last modified on 2019/07/29

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Basic information
Public title Multi-center prospective observational study verifying the
feasibility of molecular genetic testing for pediatric
patients with acute lymphoblastic leukemia. : JCCG ALL-18
study.
Acronym JCCG ALL-18 study
Scientific Title Multi-center prospective observational study verifying the
feasibility of molecular genetic testing for pediatric
patients with acute lymphoblastic leukemia. : JCCG ALL-18
study.
Scientific Title:Acronym JCCG ALL-18 study
Region
Japan

Condition
Condition acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To test the feasibility of molecular genetic testing for pediatric patients with acute lymphoblastic leukemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3 year event free survival and 3 year overall survival
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
25 years-old >
Gender Male and Female
Key inclusion criteria 1) Newly diagnosed acute lymphoblastic leukemia
2) Registered to CHM-14 study
3) Age below 25 years old
4) can send samples to central diagnosis
5) informed consent from patients or guardians
Key exclusion criteria Judged to be inappropriate for registration by investigators
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Katsuyoshi
Middle name
Last name Koh
Organization Saitama Children's Medical Center
Division name Department of Hematology/Oncology
Zip code 330-8777
Address 1-2, shintoshin, Chuo-ku, Saitama-shi, Saitama
TEL 048-601-2200
Email kkoh-tokyo@umin.ac.jp

Public contact
Name of contact person
1st name Katsuyoshi
Middle name
Last name Koh
Organization Saitama Children's Medical Center
Division name Department of Hematology/Oncology
Zip code 330-8777
Address 1-2, shintoshin, Chuo-ku, Saitama-shi, Saitama
TEL 048-601-2200
Homepage URL
Email kkoh-tokyo@umin.ac.jp

Sponsor
Institute Japan Children's Cancer Study Group
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Children's Medical Center, ethical committee
Address 1-2, shintoshin, Chuo-ku, Saitama-shi, Saitama
Tel 048-601-2200
Email n581811@pref.saitama.lg.jp

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
2019 Year 02 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
2019 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 01 Month 31 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 3 year event free survival and 3 year overall survival

Management information
Registered date
2019 Year 01 Month 27 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040653

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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