UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001921 |
|---|---|
| Receipt number | 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 08:40:29 |
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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
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
shagiwar@icmj.hosp.go.jp
Sponsor or person
Institute
International Medical Center of JAPAN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002338
