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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029676
Receipt No. R000033910
Scientific Title Detection of MYD88 L265P Mutation By Next Generation Deep Sequencing in Peripheral Blood Mononuclear Cells of Waldenstrom Macroguloblinemia and IgM Monoclonal Gammopathy of Undetermined Significance
Date of disclosure of the study information 2017/10/25
Last modified on 2017/10/23

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Basic information
Public title Detection of MYD88 L265P Mutation By Next Generation Deep Sequencing in Peripheral Blood Mononuclear Cells of Waldenstrom Macroguloblinemia and IgM Monoclonal Gammopathy of Undetermined Significance
Acronym Detection of MYD88 L265P Mutation By Next Generation Deep Sequencing
Scientific Title Detection of MYD88 L265P Mutation By Next Generation Deep Sequencing in Peripheral Blood Mononuclear Cells of Waldenstrom Macroguloblinemia and IgM Monoclonal Gammopathy of Undetermined Significance
Scientific Title:Acronym Detection of MYD88 L265P Mutation By Next Generation Deep Sequencing
Region
Japan

Condition
Condition Waldenstrom macroglobulinaemia, IgM Monoclonal gammopathy of undetermined significance
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The main purpose of this study is to assess the clinical implication of MYD88 mutation burden detected by NGS technique using unselected PBMCs.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and sensitivity of NGS analysis for MYD88 L265P mutation
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 Waldenstrom Macroguloblinemia, Lymphoplasmacytic Lymphoma, and IgM Monoclonal Gammopathy of Undetermined Significance
Key exclusion criteria none
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Nakaseko
Organization Chiba University Graduate School of Medicine
Division name Clinical Cell Biology and Medicine
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Email chiaki-nakaseko@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Takeuchi
Organization Chiba University Hospital
Division name Department of hematology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email m-takeuchi@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization self funding
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 千葉大学医学部附属病院(千葉県)、旭中央病院(千葉県)、亀田総合病院(千葉県)、大網病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 25 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The main purpose of this study is to assess the clinical implication of MYD88 mutation burden detected by NGS technique using unselected PBMCs.

Management information
Registered date
2017 Year 10 Month 23 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033910

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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