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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010874
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012721

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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