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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048023
Receipt No. R000054690
Scientific Title Analysis of related genes in myeloproliferative neoplasms and related diseases
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/09

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Basic information
Public title Genetic analysis in myeloid neoplasms
Acronym Genetic analysis in myeloid neoplasms
Scientific Title Analysis of related genes in myeloproliferative neoplasms and related diseases
Scientific Title:Acronym Genetic analysis in myeloproliferative neoplasms
Region
Japan

Condition
Condition myeloproliferative neoplasms and related diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Among myeloproliferative neoplasms, polycythemia vera and research on the JAK2 gene mutations is progressing, but the cause and prognosis are currently unclear in cases that are difficult to diagnose or related diseases.
Myeloproliferative neoplasms increase in people over the age of 50, but although 10% of cases have a family history and some have developed in young people, no cases of genetic mutations in germline have been reported so far. In this research, we analyze genetic abnormalities in myeloproliferative neoplasms and related diseases, and clarify whether they are acquired or involved in the onset and progression.
Basic objectives2 Others
Basic objectives -Others Analysis of genetic abnormalities in myeloproliferative neoplasms and related diseases.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Genetic mutations
Key secondary outcomes Mode of onset
Progression

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with myeloproliferative neoplasms or related diseases who have been admitted to the Department of Hematology, International University of Health and Welfare Narita Hospital during the period from the time of the Ethics Committee's approval until January 31, 2023.
(2) Patients who can obtain voluntary consent to participate in research in writing from the principal.
(3) Patients whose age at the time of obtaining consent is 18 years or older.
(4) In cases where familial onset is suspected, family members are also eligible.
Key exclusion criteria (1) Patients judged by the Research Supervisor to be inappropriate as a test subject.
(2) Cases considered to be reactive cythemia.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Mori
Organization International university of health and welfare Narita Hospital
Division name Hematology
Zip code 2868520
Address 852 Hatakeda, Narita, Cjiba
TEL 0476355600
Email mmoridh@iuhw.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Mori
Organization International University of Health and Welfare Narita Hospital
Division name Hematology
Zip code 2868520
Address 852 Hatakeda, Narita, Cjiba
TEL 0476355600
Homepage URL
Email mmoridh@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and Welfare, Ethics Committee
Address 852 Hatakeda, Narita, Cjiba
Tel 0476355613
Email rinri_md@iuhw.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
2022 Year 06 Month 17 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 20 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will analyze the relationship between genetic mutations, onset, and progression.

Management information
Registered date
2022 Year 06 Month 10 Day
Last modified on
2022 Year 06 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054690

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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