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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001747
Receipt No. R000002107
Scientific Title Research for the international hermonization of molecular responce criteria in chronic myelogenous leukemia
Date of disclosure of the study information 2009/03/03
Last modified on 2010/10/04

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Basic information
Public title Research for the international hermonization of molecular responce criteria in chronic myelogenous leukemia
Acronym Research for the international hermonization of molecular responce criteria in chronic myelogenous leukemia
Scientific Title Research for the international hermonization of molecular responce criteria in chronic myelogenous leukemia
Scientific Title:Acronym Research for the international hermonization of molecular responce criteria in chronic myelogenous leukemia
Region
Japan

Condition
Condition chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study is designed to calculate and establish the conversion factor of molecular response in Japanese chronic myeloid leukemia for the international hermonization. The calculation is based on the international scale for measurement BCR-ABL transcripts.
Basic objectives2 Others
Basic objectives -Others Definition of a criteria for therapeutic effect
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Calculate and establish the conversion factor for converting BCR-ABL mRNA value to the International Scale.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with chronic myeloid leukemia who have achieved a major cytogenetic response
2.BCR-ABL mRNA is detectable.
3.Written informed consent
Key exclusion criteria Not determined
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Sakamaki
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Department of Hematology
Zip code
Address 18-22,Honkomagome 3chome,Bunkyo-ku,Tokyo 113-8677, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chikashi Yoshida
Organization National Hospital Organization, Mito Medical Center
Division name Department of Hematology
Zip code
Address Sakuranosato 280, Ibaraki-machi, Higashiigaraki-gun, Ibaraki 311-3193, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kanto CML Study Group
Institute
Department

Funding Source
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 03 Month 03 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 Completed
Date of protocol fixation
2009 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
2010 Year 08 Month 01 Day
Date trial data considered complete
2010 Year 08 Month 01 Day
Date analysis concluded
2010 Year 08 Month 01 Day

Other
Other related information Calculate and establish the conversion factor for converting BCR-ABL mRNA value to the International Scale.

Management information
Registered date
2009 Year 03 Month 03 Day
Last modified on
2010 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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