UMIN-CTR Clinical Trial

Basic information
Public title	A study on the feasibility of the clinical sequence in pediatric hematological malignancies
Acronym	A study on the feasibility of the clinical sequence in pediatric hematological malignancies (JPLSG-CSeq-17)
Scientific Title	A study on the feasibility of the clinical sequence in pediatric hematological malignancies
Scientific Title:Acronym	A study on the feasibility of the clinical sequence in pediatric hematological malignancies (JPLSG-CSeq-17)
Region	Japan

Condition
Condition	Hematological malignancy
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To assess the feasibility of the clinical sequence in pediatric hematological malignancies by calculating the proportion of cases with potentially interventional findings by the target sequence analysis. The primary endpoint is the proportion of cases in which potentially actionable findings (PAF) are identified by the introducing the clinical sequence.
Basic objectives2	Others
Basic objectives -Others	/Proportion of identification of clinically impactful findings (CIF) /An average number of days to return analysis results to the attending doctor /Proportion of cases unable to analyze genome and the cause /Proportion of cases in which germline mutation to be returned was identified
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of cases in which PAF was identified by introducing the clinical sequence.
Key secondary outcomes	/Proportion of identification of CIF /An average number of days to return analysis results to the attending doctor /Proportion of cases unable to analyze genome and the cause /Proportion of cases in which germline mutation to be returned was identified

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	40 years-old >
Gender	Male and Female
Key inclusion criteria	/Initial ALL (B-others of IR*, HR**, remission induction failure, or T-ALL) Or recurrent ALL (regardless of the number of relapses) Or initial AML Or recurrent AML (regardless of the number of relapses) /Cases registered in JPLSG-CHM-14 /Cases in which each sample of gene-analyzable tumor and normal cell (including remission phase) is obtained Tumor: bone marrow fluid (specimen with tumor cell ratio of 20% or more) Normal cell (including remission phase): peripheral blood in remission, and oral mucosa /Provided written consent by themselves/the representatives. *IR: other than HR and NCI-HR Or PGR, NCI-SR, and M3 on day 15. However, IR rises to HR in case of non-remission at TP1 (day 33). **HR: with one or more of the following HR factors: CNS 3 on day 1; PPR on day 8; MLL-AF4-positive by day 15; PGR, NCR-HR at PGR, and MG of day 15; E2A-HLF gene abnormality by day 29; or hypodiploid (44 or less) by day 29.
Key exclusion criteria	/Cases judged inappropriate for this study by the principal investigator or sub-investigators /Cases scheduled to participate in other studies for treatment purposes (sponsor-initiated clinical trials, investigator-initiated clinical trials, interventional clinical trials)
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Manabe
Organization	St.Luke's International Hospital
Division name	Department of Pediatrics
Zip code
Address	9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL	03-3541-5151
Email	manabe-luke@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinsuke Hirabayashi
Organization	St.Luke's International Hospital
Division name	Department of Pediatrics
Zip code
Address	9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL	03-3541-5151
Homepage URL
Email	hirabayashi-slh@umin.ac.jp

Sponsor
Institute	Japan Children's Cancer Group
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 25 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	Preinitiation
Date of protocol fixation	2018 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 25 Day
Last follow-up date	2019 Year 09 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Exploratory endpoint: proportion of medical treatment conducted based on PAF after 6 months (180 days)

Management information
Registered date	2018 Year 09 Month 23 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038908