UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037331 |
|---|---|
| Receipt number | R000042558 |
| Scientific Title | Construction of image diagnosis support system by artificial intelligence in patients with psoriatic arthritis |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2020/08/26 12:16:43 |
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Basic information
Public title
Construction of image diagnosis support system by artificial intelligence in patients with psoriatic arthritis
Acronym
Construction of image diagnosis support system by artificial intelligence in patients with psoriatic arthritis
Scientific Title
Construction of image diagnosis support system by artificial intelligence in patients with psoriatic arthritis
Scientific Title:Acronym
Construction of image diagnosis support system by artificial intelligence in patients with psoriatic arthritis
Region
| Japan |
Condition
Condition
psoriatic arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Image information including ultrasound of patients with psoriatic arthritis is accumulated from multiple centers in Nagasaki University Hospital to evaluate the usefulness of imaging examination, and collect data for construction of imaging diagnosis support system by AI.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To collect US data for training and validation of imaging for construction of imaging diagnostic support system with AI that differentially diagnoses psoriatic arthritis patients and disease control.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Psoriatic arthritis patients
Patients who have a definite diagnosis of PsA (CASPAR criteria) from January 1, 2010 to December 31, 2020.
2. Disease control; RA or HOA
Patients who have been diagnosed with RA or HOA from 1 January 2010 to 31 December 2020.
Key exclusion criteria
Patients judged by researchers as inappropriate for study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Kawashiri |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of community medicine
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
095-819-7189
Homepage URL
shin-ya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7200
mh_shomu@ml.nagasaki-u.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
| 2019 | Year | 07 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To accumulate images and stored serum.
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042558
| Research Plan | |
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| 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 |
