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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001385
Receipt No. 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

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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
Email

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
Email sugiura-isamu@toyohashi-mh.jp

Sponsor
Institute Japan Myeloma Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001685

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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