UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001747 |
|---|---|
| Receipt number | 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 20:36:38 |
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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
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
Sponsor or person
Institute
Kanto CML Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
