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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000483
Receipt No. R000000585
Scientific Title Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.
Date of disclosure of the study information 2006/09/30
Last modified on 2008/12/21

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Basic information
Public title Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.
Acronym Analysis of intracellular elements
Scientific Title Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.
Scientific Title:Acronym Analysis of intracellular elements
Region
Japan

Condition
Condition Intaractable blood diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In order to diagnose intractable blood diseases, we analyze multiple intracellular element proportion and distribution using blood / bone marrow cells derived from healthy volunteers or from blood disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Multiple element proportional and distribution analysis
Key secondary outcomes Elemental pattern corresponding to pathogenesis

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 Patients with hematological disorder;
Acute myeloblastic leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphoid leukemia, myelodysplastic syndrome, myelofibrosis, polycythemia vera, aplastic anemia, multiple myeloma, primary macrogloblinemia, PNH)
Informed consent from the patient must be obtained.
Key exclusion criteria The patient without informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Shimura
Organization Research Institute, International Medical Center of Japan
Division name Dept of intractable diseases
Zip code
Address 1-21-1,Toyama,Sinjuku-ku,Tokyo 162-8655, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Hagiwara
Organization International Medical Center of Japan
Division name Hospital, Hematology division of Internal Medicine
Zip code
Address 1-21-1,Toyama,Sinjuku-ku,Tokyo 162-8655, Japan
TEL
Homepage URL
Email shagiwar@imcj.hosp.go.jp

Sponsor
Institute Grants in Research on Advanced Medical Technology from the Ministry of Health and Labor, and Welfare of Japan since April 2006
Institute
Department

Funding Source
Organization Grants-in Research on Advanced Medical Technology from the Ministry of Health and Labor, and Welfare of Japan since April 2006
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2006 Year 09 Month 30 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
Date of protocol fixation
2006 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Intracellular elements pattern and distribution

Management information
Registered date
2006 Year 09 Month 09 Day
Last modified on
2008 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000585

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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