UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022763 |
|---|---|
| Receipt number | R000020846 |
| Scientific Title | Evaluation and development of the novel measurement method for multiple myeloma |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2016/12/16 13:44:14 |
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Basic information
Public title
Evaluation and development of the novel measurement method for multiple myeloma
Acronym
Novel measurement method for multiple myeloma
Scientific Title
Evaluation and development of the novel measurement method for multiple myeloma
Scientific Title:Acronym
Novel measurement method for multiple myeloma
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the methods of the detection for 1q21 amplification by FISH analysis and the minimal residual disease using multi-color flow cytometry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of 1q21 amplification and minimal residual disease with clinical response and other laboratory parameter
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
| Other |
Interventions/Control_1
Classification of myeloma cells and the detection of minimal residual disease by analysis of gene amplication of 1q21, 8 color flowcytometry
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
Newly and previously diagnosed multiple myeloma patients with written informed consent
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
shagiwar@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
Homepage URL
shagiwar@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and 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
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
| 2016 | Year | 06 | Month | 16 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020846
