UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002516 |
|---|---|
| Receipt number | R000003079 |
| Scientific Title | Multicenter clinical study evaluating iron metabolism in patinets with bone marrow failure syndromes |
| Date of disclosure of the study information | 2009/09/24 |
| Last modified on | 2014/03/19 11:32:05 |
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Basic information
Public title
Multicenter clinical study evaluating iron metabolism in patinets with bone marrow failure syndromes
Acronym
Multicenter clinical study evaluating iron metabolism in patinets with bone marrow failure syndromes
Scientific Title
Multicenter clinical study evaluating iron metabolism in patinets with bone marrow failure syndromes
Scientific Title:Acronym
Multicenter clinical study evaluating iron metabolism in patinets with bone marrow failure syndromes
Region
| Japan |
Condition
Condition
Patients with bone marrow failure syndromes who have no history of red blood cell transfusion
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating iron metabolism in patinets with bone marrow failure syndromes
Basic objectives2
Others
Basic objectives -Others
Evaluating iron metabolism in patinets with bone marrow failure syndromes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluating data of iron metabolism, e.g. serum iron and serum ferritin levels.
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
Patients diagnosed with myelodysplastic syndrome or aplastic anemia or pure red cell aplasia or primary myelofibrosis.
Patients without any history of red blood cell transfusion.
Patients without any iron preparations after diagnosis.
Without any obvious bleeding or hemolysis.
With written informed consent by patients.
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiya Ozawa |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL
0285-58-7353
hematology@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL
0285-58-7353
Homepage URL
hematology@jichi.ac.jp
Sponsor or person
Institute
The National Research Group on Idiopathic Bone Marrow Failure Syndromes in Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 | 09 | Month | 24 | 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
| 2008 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On the occasion of registration and after one year (or when the first red blood cell transfusion is initiated), evaluate clinical laboratory data, e.g. blood count, blood chemistry (including iron-related examinations).
Management information
Registered date
| 2009 | Year | 09 | Month | 17 | Day |
Last modified on
| 2014 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003079
