UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034243
Receipt number R000038908
Scientific Title A study on the feasibility of the clinical sequence in pediatric hematological malignancies
Date of disclosure of the study information 2018/09/25
Last modified on 2019/09/24 13:04:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Japan Children's Cancer Group

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name