UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016522 |
|---|---|
| Receipt number | R000019186 |
| Scientific Title | Survey of Medical Cost and Livelihood of CML Patients |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2015/11/30 14:52:47 |
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Basic information
Public title
Survey of Medical Cost and Livelihood of CML Patients
Acronym
Survey of Medical Cost and Livelihood of CML Patients
Scientific Title
Survey of Medical Cost and Livelihood of CML Patients
Scientific Title:Acronym
Survey of Medical Cost and Livelihood of CML Patients
Region
| Japan |
Condition
Condition
CML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of burden and anxiety for the future of health care costs
Basic objectives2
Others
Basic objectives -Others
Measurement of utility for CML patients
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of burden and anxiety for the future of health care costs
Key secondary outcomes
QOL of CML patients, percentage of income and medical expenses, drug compliance
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
(1) received medical treatment
(2) under drug therapy, or a drug treatment experience.
(3) received a description of the research
(4) more than three years from the start of treatment.
Key exclusion criteria
(1) do not use of the high-cost medical care system.
(2) being welfare certification
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo OHASHI |
Organization
Chuo University
Division name
Department of Integrated Science and Engineering for Sustainable Society
Zip code
Address
Kasuga Bunkyo-ku TOKYO
TEL
03-3817-1715
ohashiy.00e@g.chuo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira NIWA |
Organization
Nonprofit Organization, Japan Clinical Research Support Unit
Division name
Health Outcome Research Promotion Team
Zip code
Address
Sotokanda Chiyoda-ku TOKYO
TEL
03-3254-8028
Homepage URL
niwa@crsu.org
Sponsor or person
Institute
Nonprofit Organization, Japan Clinical Research Support Unit
Institute
Department
Personal name
Funding Source
Organization
Nonprofit Organization, TSUBASA
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近畿大学（大阪府）、NTT東日本関東病院（東京都）、藤沢市民病院（神奈川県）、大阪市大（大阪府）、札幌北楡病院（北海道）、長崎大学（長崎県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 12 | 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
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Survey for CML Patients
Management information
Registered date
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
