UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020757 |
|---|---|
| Receipt number | R000023954 |
| Scientific Title | Epidemiological study of Intravascular large B-cell lymphoma in Hokuriku |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2019/07/31 15:24:21 |
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Basic information
Public title
Epidemiological study of Intravascular large B-cell lymphoma in Hokuriku
Acronym
Epidemiology of IVL in Hokuriku
Scientific Title
Epidemiological study of Intravascular large B-cell lymphoma in Hokuriku
Scientific Title:Acronym
Epidemiology of IVL in Hokuriku
Region
| Japan |
Condition
Condition
Intravascular large B -cell lymphoma (IVLBCL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze epidemiology of IVLBCL in Hokuriku
Basic objectives2
Others
Basic objectives -Others
To confirm incidence of IVLBCL not only eligible cases to therapeutic study but also ineligible cases in Hokuriku district, and examine recent prognostic improvement.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of the incidence of annual IVLBCL in the Hokuriku district
Key secondary outcomes
The proportion of patients that chemotherapy were administered.
Overall survival.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, IVLBCL cases or similar systemic disseminated DLBCL cases who were taken ill since 2006 until 2016 in Hokuriku district.
2, No matter whether who have been treated or not.
Key exclusion criteria
obvious nodular DLBCL cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasufumi |
| Middle name | |
| Last name | Masaki |
Organization
Kanazawa Medical University
Division name
Department of Hematology and Immunology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-3511
yasum@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasufumi |
| Middle name | |
| Last name | Masaki |
Organization
Kanazawa Medical University
Division name
Department of Hematology and Immunology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-3511
Homepage URL
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
Tel
076-286-3511
yasum@kanazawa-med.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
金沢大学、金沢医科大学、国立病院機構金沢医療センター、石川県立中央病院、恵寿金沢病院（石川県）。富山大学、富山県立中央病院、黒部市民病院、砺波総合病院、富山赤十字病院、富山市立病院、真生会富山病院、金沢医科大学氷見市民病院（富山県）。あわら病院、福井県立病院、福井赤十字病院、国立病院機構福井病院、福井大学、福井済生会病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
We collect information with a database from facilities with hematology of three prefectures of Hokuriku.
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023954
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/28 | IVLBCL疫学研究プロトコール-改訂3.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
