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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001921
Receipt No. R000002338
Scientific Title Element array analysis in patients with hematological disorder using inductively coupled plasma mass spectrometry
Date of disclosure of the study information 2009/05/07
Last modified on 2017/06/21

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Basic information
Public title Element array analysis in patients with hematological disorder using inductively coupled plasma mass spectrometry
Acronym Element array analysis using ICP-MS
Scientific Title Element array analysis in patients with hematological disorder using inductively coupled plasma mass spectrometry
Scientific Title:Acronym Element array analysis using ICP-MS
Region
Japan

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

Objectives
Narrative objectives1 To investigate disease specific pattern of trace elements in patients with hematological diseases.
Basic objectives2 Others
Basic objectives -Others We have studied intracellular elements of blood or bone marrow cells from hematological diseases using scanning x-ray fluorescence microscopy (UMIN000000483). In this study, we analyze quantity of trace elements. A part of the samples obtained in the previous study (UMIN000000483) will be included.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Quantity of trace elements in plasma and/or bone marrow mononuclear cells
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 1.Patients with hematological diseases
2.Healthy volunteer

Key exclusion criteria Patients and volunteer without written informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shotaro Hagiwara
Organization International Medical Center of JAPAN
Division name Hematology
Zip code
Address 1-21-1Toyama, Shinjuku, Tokyo
TEL 03-3202-7181
Email shagiwar@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Hagiwara
Organization International Medical Center of JAPAN
Division name Division of Hematology
Zip code
Address 1-21-1Toyama, Shinjuku, Tokyo, JAPAN
TEL +81-3-3202-7181
Homepage URL
Email shagiwar@icmj.hosp.go.jp

Sponsor
Institute International Medical Center of JAPAN
Institute
Department

Funding Source
Organization International Medical Center of JAPAN
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
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
2009 Year 05 Month 07 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 Completed
Date of protocol fixation
2009 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 10 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate disease specific variation of trace element in patients with hematological disorders, We measure trace element of patients and healthy volunteer using ICP-MS, and compare the element array of both groups.
A part of samples which were collected after January 18,2008 in the previous study UMIN000000483 will be included in the subjects of the analysis.

Management information
Registered date
2009 Year 04 Month 30 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002338

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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