UMIN-CTR Clinical Trial

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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