UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000483
Receipt number R000000585
Scientific Title Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.
Date of disclosure of the study information 2006/09/30
Last modified on 2008/12/21 18:33:15

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Basic information

Public title

Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.

Acronym

Analysis of intracellular elements

Scientific Title

Analysis of intracellular elements of blood or bone marrow cells from blood diseases patients using scanning x-ray fluorescence microscopy.

Scientific Title:Acronym

Analysis of intracellular elements

Region

Japan


Condition

Condition

Intaractable blood diseases

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In order to diagnose intractable blood diseases, we analyze multiple intracellular element proportion and distribution using blood / bone marrow cells derived from healthy volunteers or from blood disease patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Multiple element proportional and distribution analysis

Key secondary outcomes

Elemental pattern corresponding to pathogenesis


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 with hematological disorder;
Acute myeloblastic leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphoid leukemia, myelodysplastic syndrome, myelofibrosis, polycythemia vera, aplastic anemia, multiple myeloma, primary macrogloblinemia, PNH)
Informed consent from the patient must be obtained.

Key exclusion criteria

The patient without informed consent

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mari Shimura

Organization

Research Institute, International Medical Center of Japan

Division name

Dept of intractable diseases

Zip code


Address

1-21-1,Toyama,Sinjuku-ku,Tokyo 162-8655, Japan

TEL

03-3202-7181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shotaro Hagiwara

Organization

International Medical Center of Japan

Division name

Hospital, Hematology division of Internal Medicine

Zip code


Address

1-21-1,Toyama,Sinjuku-ku,Tokyo 162-8655, Japan

TEL


Homepage URL


Email

shagiwar@imcj.hosp.go.jp


Sponsor or person

Institute

Grants in Research on Advanced Medical Technology from the Ministry of Health and Labor, and Welfare of Japan since April 2006

Institute

Department

Personal name



Funding Source

Organization

Grants-in Research on Advanced Medical Technology from the Ministry of Health and Labor, and Welfare of Japan since April 2006

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

2006 Year 09 Month 30 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

2006 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2006 Year 10 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Intracellular elements pattern and distribution


Management information

Registered date

2006 Year 09 Month 09 Day

Last modified on

2008 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000585


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name