UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038212 |
|---|---|
| Receipt number | R000043519 |
| Scientific Title | Validation study of haemophilia-related outcomes on Japanese electronic medical records |
| Date of disclosure of the study information | 2019/10/06 |
| Last modified on | 2021/06/24 21:13:21 |
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Basic information
Public title
Validation study of haemophilia-related outcomes on Japanese electronic medical records
Acronym
hemophilia-REAL V study
Scientific Title
Validation study of haemophilia-related outcomes on Japanese electronic medical records
Scientific Title:Acronym
hemophilia-REAL V study
Region
| Japan |
Condition
Condition
Haemophilia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop algorithms for identifying patients with hemophilia A and related outcomes in the Real World Data (RWD) database.
Basic objectives2
Others
Basic objectives -Others
Sensitivity, specificity, positive predictive value, and negative predictive value of hemophilia-related outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, and negative predictive value of hemophilia-related outcomes
Key secondary outcomes
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
Not applicable
Key exclusion criteria
Not applicable
Target sample size
238
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Kurashiki Central Hospital
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki City, Okayama, Japan
TEL
086-422-0210
tf14817@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Kurashiki Central Hospital, Kurashiki
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki City, Okayama, Japan
TEL
086-422-0210
Homepage URL
tf14817@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital, Kurashiki
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
12th floor, Sumitomo Shiba Daimon Building 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.co.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
| 2019 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
236
Results
Unpublished
Results date posted
| 2020 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
