UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048340 |
|---|---|
| Receipt number | R000055090 |
| Scientific Title | Assessment of accuracy of AI (Artificial Intelligence) algorithm for early diagnosis of joint disorders in hemophilia patients using ultrasound imaging. |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2024/07/22 09:45:48 |
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Basic information
Public title
Assessment of accuracy of AI (Artificial Intelligence) algorithm for early diagnosis of joint disorders in hemophilia patients using ultrasound imaging.
Acronym
Hemophilia US AI algorithm study
Scientific Title
Assessment of accuracy of AI (Artificial Intelligence) algorithm for early diagnosis of joint disorders in hemophilia patients using ultrasound imaging.
Scientific Title:Acronym
Hemophilia US AI algorithm study
Region
| Japan |
Condition
Condition
Hemophilia A, Hemophilia B
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to construct an AI algorithm to estimate the presence of joint bleeding and synovitis using joint ultrasound images of hemophilia patients, and to evaluate the accuracy of the algorithm.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to construct an AI algorithm to estimate the presence of joint bleeding and synovitis using joint ultrasound images of hemophilia patients, and to evaluate the accuracy of the algorithm.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of ROC curves for expert physician and AI diagnoses of joint hemorrhage and synovitis. If necessary, add correct response rate, fit rate, reproducibility, specificity, F-value, IoU, etc.
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
Patients fulfilling the following criteria (1) and (2) with joint ultrasound imagings
(1) Patients with congenital hemophilia A or congenital hemophilia B or patients other than congenital hemophilia A and B diagnosed with normal joints whose joint ultrasound images were taken between 1 January 2010 and 31 March 2022.
(2) Patients who have not expressed any refusal to the use of images and existing data in this study.
Key exclusion criteria
Patients expressing refusal to allow the use of images and existing data in this study.
Patients with diseases other than congenital hemophilia A and congenital hemophilia B with joint involvement.
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | Azusa |
| Middle name | |
| Last name | Nagao |
Organization
Ogikubo Hospital
Division name
Department of Blood Coagulation
Zip code
167-0035
Address
3-1-24 imagawa, Suginami-ku, Tokyo
TEL
03-3399-1101
azusa_nagao@ogikubo-hospital.or.jp
Public contact
Name of contact person
| 1st name | Chugai Pharmaceutical |
| Middle name | |
| Last name | Co., Ltd. |
Organization
Medical Affairs Division
Division name
Medical Science department
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3273-0866
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
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
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2022 | Year | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055090
