UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006489 |
|---|---|
| Receipt number | R000007699 |
| Scientific Title | A clinical trial evaluating the detection of minimal residual disease (MRD) in patients with chronic myeloid leukemia by DNA-PCR |
| Date of disclosure of the study information | 2011/10/05 |
| Last modified on | 2022/04/13 09:34:12 |
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Basic information
Public title
A clinical trial evaluating the detection of minimal residual disease (MRD) in patients with chronic myeloid leukemia by DNA-PCR
Acronym
Clinical trial evaluating detection of minimal residual disease in patients with chronic myeloid leukemia
Scientific Title
A clinical trial evaluating the detection of minimal residual disease (MRD) in patients with chronic myeloid leukemia by DNA-PCR
Scientific Title:Acronym
Clinical trial evaluating detection of minimal residual disease in patients with chronic myeloid leukemia
Region
| Japan |
Condition
Condition
chronic myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate the possibility of the minimal residual disease (MRD) detection in peripheral blood by using DNA-PCR method that is constructed from paraffin-embedded tissue or bone marrow cells that are stored prior to the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of BCR-ABL genomic DNA in peripheral blood collected during drug treatment (DNA-PCR method)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of BCR-ABL genomic DNA in peripheral blood samples (DNA- PCR method)
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
Chronic Myeloid Leukemia
Key exclusion criteria
Patients whose bone marrow cells or paraffin-embedded tissue prior to the treatment are not available
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
1138431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
ersato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
1138431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
Homepage URL
ersato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-3813-3111
ersato@juntendo.ac.jp
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
| 2011 | Year | 10 | Month | 05 | 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
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007699
