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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032878
Receipt No. R000037490
Scientific Title NAP expression analysis in bcr-abl negative MPN.
Date of disclosure of the study information 2018/12/31
Last modified on 2018/09/15

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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
Middle name
Last name Toshinori Kondo
Organization Kawasaki Medical School
Division name Hematology
Zip code
Address 577 Matsushima, Kurashiki city
TEL 0864621111
Email hematol@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori Kondo
Organization Kawasaki Medical School
Division name Hematology
Zip code
Address 577 Matsushima, Kurashiki city
TEL 0864621111
Homepage URL
Email hematol@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
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 12 Month 31 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 05 Day
Last modified on
2018 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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