UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000224
Receipt number R000000289
Scientific Title Investigational study for elderly acute myelocytic leukemia
Date of disclosure of the study information 2005/09/20
Last modified on 2009/03/25 07:22:03

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Basic information

Public title

Investigational study for elderly acute myelocytic leukemia

Acronym

Investigational study for elderly acute myelocytic leukemia

Scientific Title

Investigational study for elderly acute myelocytic leukemia

Scientific Title:Acronym

Investigational study for elderly acute myelocytic leukemia

Region

Japan


Condition

Condition

acute myelocytic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To analyze all cases with acute myelocytic leukemia

Basic objectives2

Others

Basic objectives -Others

Therapy limitting factor

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Therapy limitting factor

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

65 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with acute myelocytic leukemia
Age above 66 year

Key exclusion criteria

none

Target sample size

288


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Wakita, MD

Organization

Higashi Municipal Hospital of Nagoya

Division name

Hematology and Oncology

Zip code


Address

1-2-23 Wakamizu, Chikusa-ku, Nagoya, JAPAN

TEL

052-721-7171

Email



Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Wakita, MD

Organization

Higashi Municipal Hospital of Nagoya

Division name

Hematology and Oncology

Zip code


Address

1-2-23 Wakamizu, Chikusa-ku, Nagoya, JAPAN

TEL

052-721-7171

Homepage URL


Email



Sponsor or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



Funding Source

Organization

Health and Labour Science Research Grants

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


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

2005 Year 09 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

1998 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2000 Year 04 Month 01 Day

Last follow-up date

2007 Year 08 Month 01 Day

Date of closure to data entry

2007 Year 12 Month 01 Day

Date trial data considered complete

2008 Year 06 Month 01 Day

Date analysis concluded

2008 Year 12 Month 01 Day


Other

Other related information

Investigate background factors for elderly acute myelocytic leukemia


Management information

Registered date

2005 Year 09 Month 13 Day

Last modified on

2009 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000289


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name