UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022394 |
|---|---|
| Receipt number | R000025810 |
| Scientific Title | Distribution of serum erythropoietin levels in Japanese patients with myelodysplastic syndromes. |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2016/05/25 10:32:03 |
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Basic information
Public title
Distribution of serum erythropoietin levels in Japanese patients with myelodysplastic syndromes.
Acronym
Serum erythropoietin levels in Japanese patients with MDS
Scientific Title
Distribution of serum erythropoietin levels in Japanese patients with myelodysplastic syndromes.
Scientific Title:Acronym
Serum erythropoietin levels in Japanese patients with MDS
Region
| Japan |
Condition
Condition
myelodysplastic syndromes
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze distribution of serum erythropoietin (EPO) levels in Japanese patients with MDS, and to find factors that correlate with EPO.
Basic objectives2
Others
Basic objectives -Others
To analyze clinical conditions for the initiation of erythropoiesis stimulating agents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum erythropoietin (EPO) levels
Key secondary outcomes
Factors that correlate with serum EPO levels
hemoglobin, hematocrit etc.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with MDS who are treated in Jichi Medical University Hospital. All subtypes of MDS are eligible.
Key exclusion criteria
Patients who are treated with erythropoiesis stimulating agents.
Patients from whom informed consent cannot be obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 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, Tochigi
TEL
0285-58-7353
tasuzuki@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, Tochigi
TEL
0285-58-7353
Homepage URL
tasuzuki@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
| 2016 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Serum erythropoietin levels correlate negatively with hemoglobin levels, and the erythropoietin level of 500 IU/L approximately corresponds to 8.0 g/dL of hemoglobin.
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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Forty-five patients older than 20 years with MDS, who visited Jichi Medical University Hospital from June 2011 to August 2014, were enrolled. Serum EPO levels were examined, and correlations between EPO levels and other hematological parameters, e.g. hemoglobin levels, WBC/platelet/reticulocytes counts and bone marrow erythroblasts counts, were analyzed.
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025810
