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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name