UMIN-CTR Clinical Trial

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

Hematological malignancy

Classification by specialty

Hematology and clinical oncology

Pediatrics

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Children's Cancer Group

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

09

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

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