UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054709 |
|---|---|
| Receipt number | R000062517 |
| Scientific Title | Survey on the International Staging System and Chromosome Analysis Test in Multiple Myeloma Therapy |
| Date of disclosure of the study information | 2024/06/19 |
| Last modified on | 2024/12/18 16:20:52 |
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Basic information
Public title
Survey on the International Staging System and Chromosome Analysis Test in Multiple Myeloma Therapy
Acronym
Survey on the International Staging System and Chromosome Analysis Test in Multiple Myeloma Therapy
Scientific Title
Survey on the International Staging System and Chromosome Analysis Test in Multiple Myeloma Therapy
Scientific Title:Acronym
Survey on the International Staging System and Chromosome Analysis Test in Multiple Myeloma Therapy
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To grasp current use of the international staging system in multiple myeloma (MM) and describe the awareness and use of the newly established R2-ISS (Second Revision of the International Staging System) .
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To grasp current use of the international staging system in multiple myeloma (MM) and describe the awareness and use of the newly established R2-ISS.
1_Current use of each international staging system
2_Thoughts on international staging system
3_Awareness of R2-ISS
4_Current use of R2-ISS
5_Intension to use R2-ISS and the reasons
Key secondary outcomes
I. To describe the thoughts on and issues with the chromosome analysis test for MM treatment and the current measurement of 1q21gain/amplification.
II. To clarify the prospect for the chromosome analysis test as a prognostic factor in the future
1_Current use of chromosome analysis test
2_Thoughts on and issues with the chromosome analysis test
3_Current measurement of 1q21gain/amplification
4_How the 1q21gain/amplification result is used
5_Thoughts on 1q21gain/amplification measurement
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 "1 or more patients with multiple myeloma in the last year."
4_Treated "1 or more patients with multiple myeloma in the last year."
5_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 Business Intelligence Service Division
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
| 2024 | Year | 06 | Month | 19 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
*Study design
This is a cross-sectional study to be conducted online as a Web survey in hematologists treating patients with multiple myeloma.
*How to recruit subjects
The questionnaire will be distributed to all hematologist who are members of m3.com (M3, Inc.), a medical information site, and can complete a questionnaire are asked to participate in the survey, and the they will participate in the survey on a voluntary basis. Responses will be accepted without any restrictions during the survey period. However, the target number of valid responses is set at 150 due to the limit on the study costs and the acceptance of responses will be cut off at 160 (including invalid responses that are not subject to analysis).
*Data collection period
July 1, 2024 - July 31, 2024
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062517
