UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001385 |
|---|---|
| Receipt number | R000001685 |
| Scientific Title | Cytogenetic features and its clinical implications in Japanese patients with multiple myeloma: retrospective analysis by Japan Myeloma Study Group |
| Date of disclosure of the study information | 2008/09/22 |
| Last modified on | 2009/09/24 16:20:40 |
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Basic information
Public title
Cytogenetic features and its clinical implications in Japanese patients with multiple myeloma: retrospective analysis by Japan Myeloma Study Group
Acronym
Retrospective analysis in cytogenetic features and its clinical implications in Japanese multiple myeloma
Scientific Title
Cytogenetic features and its clinical implications in Japanese patients with multiple myeloma: retrospective analysis by Japan Myeloma Study Group
Scientific Title:Acronym
Retrospective analysis in cytogenetic features and its clinical implications in Japanese 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 observe the cytogenetic features in Japanese patients with multiple myeloma and to see its clinical implications.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.cytogenetic abnormalities and their prevalence
2.cytogenetic features and its clinical implications
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility:
1)asymptomatic or symptomatic multiple myeloma
2)Japanese patients
3)diagnosed and initially treated in Japan Myeloma Study Group between January 1, 1997 and December 31, 2006.
4)Cytogenetic examination using either metaphase G-banding or interphase fluorescence in situ hybridization(FISH) at least once during clinical course
Key exclusion criteria
Exclusion criteria
1) monoclonal gammopathy of undetermined significance(MGUS)
2) extramedulary plasmacytoma
3) prior history of MGUS or extramedulary plasmacytoma
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isamu Sugiura |
Organization
Toyohashi Municipal Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
50 Hakken-nishi, Aotake-cho
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Sugiura |
Organization
Toyohashi Municipal Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
TEL
Homepage URL
sugiura-isamu@toyohashi-mh.jp
Sponsor or person
Institute
Japan Myeloma Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Myeloma Study Group
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
| 2008 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
1.patients characteristics
1) sex,age
2) date of initial consultation
3) diagnosis, type of M-protein
4) stage(Durie&Salmon,ISS)
2.treatment
1) date of initial treatment
2) type of treatment(none, standard chemotherapy, high-dose chemotherapy and its types)
3. outcome
1) date of last follow up,outcome
4.chromosome analysis
1) date of examination
2) clinical stage(before or during treatment)
5. results of chromosome analysis
1) place of examination
2) G-banding
3) FISH
del(13q14)
del(17p13)
abnormalities of 11q
t(11;14)(q13;q32)
t(4;14)(p16;q32)
t(14;16)(q32;q23)
6. major cytogenetic abnormalities and prognosis
Management information
Registered date
| 2008 | Year | 09 | Month | 21 | Day |
Last modified on
| 2009 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001685
| 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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