UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001655 |
|---|---|
| Receipt number | R000001987 |
| Scientific Title | Iron metabolism in myelodysplastic syndrome focusing on plasma ferritin levels |
| Date of disclosure of the study information | 2009/02/01 |
| Last modified on | 2009/01/23 17:41:31 |
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Basic information
Public title
Iron metabolism in myelodysplastic syndrome focusing on plasma ferritin levels
Acronym
Iron metabolism in MDS
Scientific Title
Iron metabolism in myelodysplastic syndrome focusing on plasma ferritin levels
Scientific Title:Acronym
Iron metabolism in MDS
Region
| Japan |
Condition
Condition
Myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Myelodysplastic syndrome (MDS) is a hematological disorder and mostly not curable. The pathogenesis of the disease is also not fully elucidated.The aim of the study is to evaluate iron metabolism in MDS as a possible mechanism contributing to the pathogenesis.
Basic objectives2
Others
Basic objectives -Others
Analysis of pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of plasma ferritin levels between MDS and other hematological diseases
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 syndrome
Aplastic anemia
Key exclusion criteria
infection
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuiko Tsukada |
Organization
Keio University School of Medicine
Division name
Internal medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuiko Tsukada |
Organization
Keio University School of Medicine
Division name
Internal medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Yokyo
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 01 | 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
| 2008 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
plasma ferritin levels
Management information
Registered date
| 2009 | Year | 01 | Month | 24 | Day |
Last modified on
| 2009 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001987
