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Recruitment status
Unique ID issued by UMIN UMIN000000694
Receipt No. R000000831
Scientific Title Registration Program for Myelodysplastic Syndromes and Aplastic Anemia
Date of disclosure of the study information 2007/04/28
Last modified on 2010/03/19

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Basic information
Public title Registration Program for Myelodysplastic Syndromes and Aplastic Anemia
Acronym Registration for MDS and AA
Scientific Title Registration Program for Myelodysplastic Syndromes and Aplastic Anemia
Scientific Title:Acronym Registration for MDS and AA
Region
Japan

Condition
Condition Myelodysplastic Syndromes
Aplastic Anemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to obtain general agreement on diagnosis of MDS and AA. Also to clarify clinical outcomes of current treatment practice in Japan. Moreover, we utilize the collected data for development of novel therapeutic strategies.
Basic objectives2 Others
Basic objectives -Others To obtain diagnostic criteria.
To obtain treatment outcomes.
To obtain base line data for development of novel treatment strategies.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes survival rate
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 Myelodysplastic Syndromes and Aplastic Anemia
Key exclusion criteria not applicable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Okamoto
Organization Keio University School of Medicine
Division name Department of Hematology
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo
TEL 03-5363-3785
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of Hematology
Zip code
Address
TEL 03-5363-3785
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization funding from Minisrtry of Health, Labour and Welfare
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
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
2007 Year 04 Month 28 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
2007 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information survival rate

Management information
Registered date
2007 Year 04 Month 27 Day
Last modified on
2010 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000831

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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