UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000695
Receipt number R000000832
Scientific Title Specimen Aquisition Program and Genetic Analysis for Myelodysplastic Syndromes
Date of disclosure of the study information 2007/04/28
Last modified on 2010/03/19 09:51:08

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Basic information

Public title

Specimen Aquisition Program and Genetic Analysis for Myelodysplastic Syndromes

Acronym

Genetic Analysis for Myelodysplastic Syndromes

Scientific Title

Specimen Aquisition Program and Genetic Analysis for Myelodysplastic Syndromes

Scientific Title:Acronym

Genetic Analysis for Myelodysplastic Syndromes

Region

Japan


Condition

Condition

Myelodysplastic Syndromes

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The aim of the study is four folds. To reveal the pathogenesis and the mechanisms of disease progression in MDS. To identify molecules which contributes the precise diagnosis of MDS. To organize the data in optimizing therapeutic options. To identify novel molecular targets.

Basic objectives2

Others

Basic objectives -Others

Analysis of the Pathogenesis of MDS

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

To identify target molecules

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 (MDS) and Acute Myeloid Leukemia evolving from MDS.
Acute Myeloid Leukemia with Multilineage Dysplasia.

Key exclusion criteria

not applicable

Target sample size

12


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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Funding from Ministery 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

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2012 Year 03 Month 01 Day


Other

Other related information

Clinical relevance between target molecules and clnical data


Management information

Registered date

2007 Year 04 Month 27 Day

Last modified on

2010 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=R000000832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name