UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004915 |
|---|---|
| Receipt number | 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 | 2020/01/27 09:12:24 |
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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 | Junji |
| Middle name | |
| Last name | Suzumiya |
Organization
Shimane University Hospital
Division name
Cancer Center
Zip code
693-8501
Address
89-1 Enya, Izumo, Shimane 693-8501, Japan
TEL
+81-853-20-2308
suzumiya@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takizawa |
Organization
Niigata University Graduate School of Medical & Dental Sciences
Division name
Division of Hematology
Zip code
951-8510
Address
1-757 Asahi-machi doori, Niigata, 951-8510, Japan
TEL
+81-25-368-9025
Homepage URL
juntaki@med.niigata-u.ac.jp
Sponsor or person
Institute
Chronic lymphocytic leukemia and related diseases study group (CLLRSG)
Institute
Department
Personal name
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
Shimane University IRB
Address
89-1 En-ya cho, Izumo
Tel
0853202517
rsuzuki@med.shimane-u.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
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
| 2020 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005819
