UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010874 |
|---|---|
| Receipt number | R000012721 |
| Scientific Title | Development of the novel test for myelodysplastic syndrome |
| Date of disclosure of the study information | 2013/06/06 |
| Last modified on | 2013/06/04 20:02:31 |
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Basic information
Public title
Development of the novel test for myelodysplastic syndrome
Acronym
Development of the novel test for myelodysplastic syndrome
Scientific Title
Development of the novel test for myelodysplastic syndrome
Scientific Title:Acronym
Development of the novel test for myelodysplastic syndrome
Region
| Japan |
Condition
Condition
myelodysplastic syndrome
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the expression of the candidate group of proteins involved in the cause of anemia found in myelodysplastic syndrome by using immunological approach.
After examining the data obtained with discriminant analysis,
we'll evaluate whether obtaining expression of expression of candidate protein becomes effective and novel test for differentiation for myelodysplastic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After taking out peripheral blood drawing (once as a general rule), the expression of the candidate group of proteins are analyzed with flowcytemetry and ELISA methods.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemoglobin level; Less than 10g/dL
Key exclusion criteria
Minor, Underage
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke SUGIYAMA |
Organization
Kyushu University Hospital, Center for Clinical and Translational Research
Division name
Network Coordination Unit
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke SUGIYAMA Tomoko INOUE |
Organization
Kyushu University Hospital, Center for Clinical and Translational Research
Division name
Network Coordination Unit
Zip code
Address
TEL
092-642-6146
Homepage URL
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Contributions at Kyushu university
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 06 | Month | 06 | 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
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study.
Non-randomization and non-blind study.
Management information
Registered date
| 2013 | Year | 06 | Month | 04 | Day |
Last modified on
| 2013 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012721
