UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Akira Ohara
Organization	Toho University
Division name	Omori Hospital, Dep. of Transfusion
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL	81337624151
Email	aohara@med.toho-u.ac.jp

Public contact
Name of contact person	Akira Ohara
Organization	Toho University
Division name	Omori Hospital, Dep. of Transfusion
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL	81337624151
Homepage URL
Email	aohara@med.toho-u.ac.jp

Sponsor
Institute	Tokyo Children's Cancer Study Group
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004100