UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029725 |
|---|---|
| Receipt number | 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 12:25:26 |
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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
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
m-takeuchi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033964
