UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031063 |
|---|---|
| Receipt number | R000035412 |
| Scientific Title | Risk prediction of progression to multiple myeloma from MGUS or smoldering myeloma by multi-color flow cytometric analysis |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/01/30 17:10:19 |
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Basic information
Public title
Risk prediction of progression to multiple myeloma from MGUS or smoldering myeloma by multi-color flow cytometric analysis
Acronym
MM-MFC2017
Scientific Title
Risk prediction of progression to multiple myeloma from MGUS or smoldering myeloma by multi-color flow cytometric analysis
Scientific Title:Acronym
MM-MFC2017
Region
| Japan |
Condition
Condition
MGUS, smoldering myeloma, and multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We analyze the phenotypes of BM plasma cells in patients with MGUS, smoldering multiple myeloma and multiple myeloma using multi-color flow cytometer, and identify the markers to predict the progression to multiple myeloma.
Basic objectives2
Others
Basic objectives -Others
biological characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the phenotype of BM plasma cells collected from patients with MGUS, smoldering multiple myeloma and multiple myeloma using multi-color flow cytometer, and analyze the difference by the type of the diseases.
Key secondary outcomes
We identify the markers to predict the risk of progression to multiple myeloma from MGUS and smoldering myeloma.
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
Patients with MGUS, smoldering multiple myeloma and untreated multiple myeloma whose clinical diagnosis is determined accurately using medical examination containing bone marrow puncture.
Key exclusion criteria
Exclusion criteria are not set up.
However, patients who received anti-myeloma treatment are excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Takamatsu |
Organization
Fukuoka University Faculty of Medicine
Division name
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
yasushi@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takamatsu |
Organization
Fukuoka University Faculty of Medicine
Division name
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
Homepage URL
yasushi@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Kyushu Cancer Center
JCHO Kyushu Hospital
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
| 2018 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze the phenotypes of BM plasma cells in patients with MGUS, SMM and MM by multi-color flow cytometer at the diangnosis.
The analysis is repeated when the disease progression is observed.
Laboratory data including the time to progression, the time to next treatment, and overall survival, is collected.
Management information
Registered date
| 2018 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035412
| 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 |
