UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052475 |
|---|---|
| Receipt number | R000059876 |
| Scientific Title | Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2023/10/12 12:26:41 |
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Basic information
Public title
Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma
Acronym
Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma
Scientific Title
Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma
Scientific Title:Acronym
Survey on Minimal Residual Disease (MRD) Measurement in 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 analyze the current status of MRD measurement and its issues in Japan and clarify unmet medical needs
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the actual status of MRD measurement and its issues in the treatment of multiple myeloma and clarify unmet medical needs
1_Whether or not minimal residual disease (MRD) is measured
2_Whether or not imaging tests (PET/CT, MRI) are performed
3_Reasons for not measuring MRD
4_MRD measurement method
5_Criteria (detection sensitivity)
6_Purpose of measuring
7_Frequency of measurement
Key secondary outcomes
I.To clarify the prospects for the MRD measurement method as a prognostic factor in the future
II.To provide a basis for future evidence generation activities
1_Purpose of MRD measurement
2_What is needed to promote MRD measurement
3_Challenges of imaging tests
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following inclusion criteria will be included:
1_Belong to the department of hematology
2_Work at a hospital (with 80 beds or more)
3_Treated "at least 2 patients with multiple myeloma in the last year" or "at least 1 patient per month"
4_Agreed to participate in the survey
Key exclusion criteria
Not applicable
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Heigoroh |
| Middle name | |
| Last name | Shirai |
Organization
Sanofi K.K.
Division name
Oncology Medical in Specialty Care
Zip code
160-0023
Address
Tokyo Opera City Tower, 3-20- 2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-3000
Heigoroh.Shirai@sanofi.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kusaka |
Organization
Social Survey Research Information Co., Ltd.
Division name
Healthcare BI & MA Service Division Health Outcomes Research
Zip code
162-0067
Address
NMF Shinjuku EAST Bldg., 10-5 Tomihisacho, Shinjuku-ku, Tokyo, Japan
TEL
03-6709-9710
Homepage URL
HOR@ssri.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation
Address
1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2023 | Year | 10 | Month | 12 | 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
158
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the relationship between the actual status of MRD measurement and measurement decision by subgroup*
1_Whether or not minimal residual disease (MRD) is measured
2_Criteria (detection sensitivity)
*The subgroups are assumed to be as follows:
1_Type of facility
2_Number of patients with multiple myeloma seen
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059876
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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