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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029725
Receipt No. R000033964
Scientific Title Assessment of multiplex detection method for JAK2, MPL and CALR in PV, ET and MF patients
Date of disclosure of the study information 2017/10/26
Last modified on 2017/10/26

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Basic information
Public title Assessment of multiplex detection method for JAK2, MPL and CALR in PV, ET and MF patients
Acronym CHIBA MPN study
Scientific Title Assessment of multiplex detection method for JAK2, MPL and CALR in PV, ET and MF patients
Scientific Title:Acronym CHIBA MPN study
Region
Japan

Condition
Condition Polycythemia vera, Essential thorombocythemia, Myelofibrosis
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study objective is to clarify the sensitivity and specificity of novel technique to identify JAK2, MPL and CALR mutation in PV, ET and MF patients.
Basic objectives2 Others
Basic objectives -Others To establish new detection method for JAK2, MPL and CALR mutation.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The sensitivity and specificity of novel technique to identify JAK2, MPL and CALR mutation
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria PV, ET and MF patients
Key exclusion criteria None
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emiko Sakaida
Organization Chiba University Hospital
Division name Department of hematology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Email esakaida@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Takeuchi
Organization Chiba University Hospital
Division name Department of Hematolgy
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email m-takeuchi@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 千葉大学医学部附属病院(千葉県)、君津中央病院(千葉県)、国際医療福祉大学三田病院(東京)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 26 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
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To establish novel detection technique for JAK2, MPL and CALR mutation.

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033964

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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