UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035689 |
|---|---|
| Receipt number | 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 | 2024/01/31 09:14:54 |
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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
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
kkoh-tokyo@umin.ac.jp
Sponsor or person
Institute
Japan Children's Cancer Study Group
Institute
Department
Personal name
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
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
1800
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
No longer 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
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040653
