UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039498 |
|---|---|
| Receipt number | R000043265 |
| Scientific Title | Japan Apheresis Registry |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/12/06 17:18:37 |
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Basic information
Public title
Japan Apheresis Registry
Acronym
JAR
Scientific Title
Japan Apheresis Registry
Scientific Title:Acronym
JAR
Region
| Japan |
Condition
Condition
Any Conditions Requiring Therapeutic Apheresis
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Urology | Neurosurgery |
| Cardiovascular surgery | Laboratory medicine | Emergency medicine |
| Blood transfusion | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to capture the entire picture of therapeutic apheresis performed in the registered facilities of JSFA, by which the effectiveness and safety data will be collected.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of indications and therapeutic conditions of apheresis therapies
Key secondary outcomes
1. Association between primary outcomes and patient characteristics.
2. Adverse events and their details
3. Patient survival for one year
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
All the patients who received apheresis therapy at the facility which participates in this registry during the study period and who or whose care-givers do not express their intention to opt-out from this registry.
Key exclusion criteria
The patients who or whose care givers expressed their intention to opt-out from this registry, or the patients who were judged ineligible for the study by the doctors in charge
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Matsuo |
Organization
Japanese Society for Apheresis
Division name
Working Group for Japan Apheresis Registry
Zip code
169-0072
Address
2-4-12 Okubo, Shinjuku-ku, Tokyo
TEL
03-5291-6231
apheresis@shunkosha.com
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Hanafusa |
Organization
Japanese Society for Apheresis
Division name
Working Group for Japan Apheresis Registry
Zip code
169-0072
Address
2-4-12 Okubo, Shinjuku-ku, Tokyo
TEL
03-5291-6231
Homepage URL
apheresis@shunkosha.com
Sponsor or person
Institute
Japanese Society for Apheresis
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Apheresis
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
The University of Tokyo, School of Medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data to be collected:
Facility data
Patient data
Therapeutic conditions
Adverse events if any
Management information
Registered date
| 2020 | Year | 02 | Month | 16 | Day |
Last modified on
| 2020 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043265
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
