UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032878
Receipt number R000037490
Scientific Title NAP expression analysis in bcr-abl negative MPN.
Date of disclosure of the study information 2018/12/31
Last modified on 2023/04/07 10:02:23

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Basic information

Public title

NAP expression analysis in bcr-abl negative MPN.

Acronym

NAP expression analysis in bcr-abl negative MPN.

Scientific Title

NAP expression analysis in bcr-abl negative MPN.

Scientific Title:Acronym

NAP expression analysis in bcr-abl negative MPN.

Region

Japan


Condition

Condition

MPN

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is investigating of NAP expression mechanism in MPN patients.

Basic objectives2

Others

Basic objectives -Others

The aim of this study is investigating of NAP expression mechanism in MPN patients.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in NAP expression level according to the genetic mutation in a MPN patient.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

JAK2-V617F mutants

Interventions/Control_2

CALR mutants

Interventions/Control_3

Normal control

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


Not applicable

Gender

Male and Female

Key inclusion criteria

MPN patients who is known genetic mutation.

Key exclusion criteria

Non.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Toshinori
Middle name
Last name Kondo

Organization

Kawasaki Medical School

Division name

Hematology

Zip code

7010192

Address

577 Matsushima, Kurashiki city

TEL

0864621111

Email

kondot@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Toshinori
Middle name
Last name Kondo

Organization

Kawasaki Medical School

Division name

Hematology

Zip code

7010192

Address

577 Matsushima, Kurashiki city

TEL

0864621111

Homepage URL


Email

kondot@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawasaki Medical School

Address

577 Matsushima Kurashiki

Tel

0864621111

Email

kondot@med.kawasaki-m.ac.jp


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 12 Month 31 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

35

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

2018 Year 06 Month 05 Day

Date of IRB

2018 Year 07 Month 09 Day

Anticipated trial start date

2018 Year 06 Month 05 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 05 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037490


Research Plan
Registered date File name
2022/06/08 様式8(2021.6版)研究計画書(一般用) (3875-01).docx

Research case data specifications
Registered date File name
2022/06/08 JAK2VF allele量検証研究データシート(3875-01).xlsx

Research case data
Registered date File name
2022/06/08 Table 1 revised ver.1.xlsx