UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003375 |
|---|---|
| Receipt number | R000004100 |
| Scientific Title | Prospective cohort study of pediatric acute lymphoblastic leukemia patients treated with Tokyo Children's Cancer Study Group risk stratification TCCSG ALL L09-1603.version1.1 |
| Date of disclosure of the study information | 2010/03/26 |
| Last modified on | 2018/09/29 13:45:29 |
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Basic information
Public title
Prospective cohort study of pediatric acute lymphoblastic leukemia patients treated with Tokyo Children's Cancer Study Group risk stratification TCCSG ALL L09-1603.version1.1
Acronym
Prospective cohort study of pediatric ALL treated with TCCSG risk stratification TCCSG ALL L09-1603 v1.1
Scientific Title
Prospective cohort study of pediatric acute lymphoblastic leukemia patients treated with Tokyo Children's Cancer Study Group risk stratification TCCSG ALL L09-1603.version1.1
Scientific Title:Acronym
Prospective cohort study of pediatric ALL treated with TCCSG risk stratification TCCSG ALL L09-1603 v1.1
Region
| Japan |
Condition
Condition
Acute Lymphoblastic Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This clinical observation study aims to evaluate an outcome of ALL children treated with TCCSG risk stratification. The stratification is based on age, WBC number, prednosolone-monotherapy response, immuno phenotype and cytogenetics. Immunophenotype and cytogenetic information are standardized with TCCSG central laboratory. Pediatric patients are registered and followed up annually. Although three types of risk adopted treatments: TCCSG ALL L1602 are recommended, there is no obligation of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
5y event free survival
5y overall survival
Key secondary outcomes
The frequency of therapy toxicity
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
previously untreated pediatric ALL patients age between 1 and 18years.
Written informed consent to participate this observational study
Key exclusion criteria
secondary leukemia
previously treated patients
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ohara |
Organization
Toho University
Division name
Omori Hospital, Dep. of Transfusion
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL
81337624151
aohara@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ohara |
Organization
Toho University
Division name
Omori Hospital, Dep. of Transfusion
Zip code
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL
81337624151
Homepage URL
aohara@med.toho-u.ac.jp
Sponsor or person
Institute
Tokyo Children's Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Children's Cancer Association of Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
No
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
61施設
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 01 | Day |
Other
Other related information
No
Management information
Registered date
| 2010 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004100
