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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004915
Receipt No. R000005819
Scientific Title Prospective observation study of chronic lymphocytic leukemia, hairy cell leukemia and related diseases in Japan (CLLRSG-01)
Date of disclosure of the study information 2011/01/20
Last modified on 2019/01/26

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Basic information
Public title Prospective observation study of
chronic lymphocytic leukemia, hairy
cell leukemia and related diseases
in Japan (CLLRSG-01)
Acronym Investigational study of chronic lymphocytic leukemia, hairy cell leukemia and related diseases in Japan (CLLRSG-01)
Scientific Title Prospective observation study of
chronic lymphocytic leukemia, hairy
cell leukemia and related diseases
in Japan (CLLRSG-01)
Scientific Title:Acronym Investigational study of chronic lymphocytic leukemia, hairy cell leukemia and related diseases in Japan (CLLRSG-01)
Region
Japan

Condition
Condition chronic lymphocytic leukemia, hairy
cell leukemia and related diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The incidence of somatic hypermutation of immunoglobulin heavy chain gene and overall survival rate of each group in Japanese patients with indolent B-cell neoplasms will be clarified.
Basic objectives2 Others
Basic objectives -Others Descriptive epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of somatic hypermutation of immunoglobulin heavy chain gene of each group in Japanese patients with indolent B-cell neoplasms
Key secondary outcomes The overall survival rate of mutated and un-mutated subgroups, overall survival period and survival time from treatment initiation in Japanese patients with indolent B-cell neoplasms

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 Untreated, B-cell chronic lymphocytic leukemia, B-cell prolymphocytic leukemia, hairy cell leukemia,and other indolent B-cell leukemias fulfilling
(1)absolute iymphocyte count of 5000/ul or more in the peripheral blood or (2)abnormal lymphocytes of 20% or more in the peripheral blood.
Key exclusion criteria Nothing special.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Suzumiya
Organization Shimane University Hospital
Division name Cancer Center
Zip code
Address 89-1 Enya, Izumo, Shimane 693-8501, Japan
TEL +81-853-20-2308
Email suzumiya@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Takizawa
Organization Niigata University Graduate School of Medical & Dental Sciences
Division name Division of Hematology
Zip code
Address 1-757 Asahi-machi doori, Niigata, 951-8510, Japan
TEL +81-25-368-9025
Homepage URL
Email juntaki@med.niigata-u.ac.jp

Sponsor
Institute Chronic lymphocytic leukemia and related diseases study group (CLLRSG)
Institute
Department

Funding Source
Organization Chronic lymphocytic leukemia and related diseases study group (CLLRSG)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 島根大学医学部附属病院(島根県)
恒仁会新潟南病院(新潟県)
新潟大学大学院医歯学総合研究科(新潟県)
順天堂大学(東京都)
虎の門病院(東京都)
NTT東日本関東病院(東京都)
慈愛会今村病院分院(鹿児島県)
神奈川県立がんセンター(神奈川県)
奈良県立医大腫瘍センター(奈良県)
日本赤十字社和歌山医療センター(和歌山県)
岡山大学病院(岡山県)
新潟県立新発田病院(新潟県)
福岡大学(福岡県)
四日市市立病院(三重県)
長崎大学大学院医歯薬学総合研究科 附属原爆後障害医療研究施設(長崎県)
群馬大学(群馬県)
横浜市立大学(神奈川県)
金沢医科大学(金沢県)
聖マリアンナ医科大学(神奈川県)
東京都健康長寿医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 20 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 No longer recruiting
Date of protocol fixation
2011 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 12 Day
Last follow-up date
2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study investigates the incidence and interval estimation of somatic hypermutation of immunoglobulin heavy chain gene in
Japanese CLL patients.

Management information
Registered date
2011 Year 01 Month 20 Day
Last modified on
2019 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005819

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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