UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029879 |
|---|---|
| Receipt number | R000034120 |
| Scientific Title | Feasibility study of clinical sequence in multiple myeloma and related Diseases; Additional study of JSH-MM-15 (JSH-MM-15-Cseq) |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2019/05/13 12:37:52 |
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Basic information
Public title
Feasibility study of clinical sequence in multiple myeloma and related Diseases;
Additional study of JSH-MM-15 (JSH-MM-15-Cseq)
Acronym
Study of clinical sequence in multiple myeloma; JSH-MM-15-Cseq
Scientific Title
Feasibility study of clinical sequence in multiple myeloma and related Diseases;
Additional study of JSH-MM-15 (JSH-MM-15-Cseq)
Scientific Title:Acronym
Study of clinical sequence in multiple myeloma; JSH-MM-15-Cseq
Region
| Japan |
Condition
Condition
Multiple myeloma and related disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the feasibility of clinical sequence in the diagnosis and treatment of multiple myeloma and related disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of potentially actionable findings(PAF),
used as a feedback to the attending physician
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A case enrolled in the JSH-MM-15 study(Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan)
2) diagnosed as having plasma cell neoplasms including symptomatic myeloma, non-secretary myeloma, multiple plasmacytoma of bone, and plasame cell leukemia
3) A case with sufficient tumor and non-tumor samples for the genomic analysis
4) A subject with written informed consent
Key exclusion criteria
A subject considered as an inappropriate participant for the current study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Iida |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Hematology and Oncology
Zip code
467-8601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
TEL
052-853-8738
iida@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Hematology and Oncology
Zip code
467-8601
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
TEL
052-853-8738
Homepage URL
rrmasaki@med.nagoya-cu.ac.jp
Sponsor or person
Institute
1) THE JAPANESE SOCIETY OF HEMATOLOGY
2) Agency for Medical Research and Development; Program for an Integrated Database of Clinical and Genomic Information; Horibe research team
Institute
Department
Personal name
Funding Source
Organization
Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCU IRB
Address
1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
日本赤十字社医療センター 血液内科
群馬大学医学部附属病院 血液内科
埼玉医科大学総合医療センター 血液内科
名古屋市立大学病院 血液・腫瘍内科
大阪大学医学部附属病院 血液・腫瘍内科
徳島大学病院 血液内科
国立病院機構 岡山医療センター 血液内科
国立病院機構 九州医療センター 血液内科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 08 | 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 | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Using the next generation sequencing, we evaluate the ratio of the MM cases with PAF(Potentially actionable findings), and evaluate the feasibility of clinical sequence in the diagnosis and treatment of multiple myeloma.
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034120
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
