UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000483 |
|---|---|
| Receipt number | 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 18:33:15 |
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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
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
shagiwar@imcj.hosp.go.jp
Sponsor or person
Institute
Grants in Research on Advanced Medical Technology from the Ministry of Health and Labor, and Welfare of Japan since April 2006
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000585
