UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048023 |
|---|---|
| Receipt number | 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 | 2023/12/11 09:31:59 |
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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
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
mmoridh@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054690
