UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062491 |
|---|---|
| Receipt number | R000071522 |
| Scientific Title | Development of Artificial Intelligence and Machine Learning (AI/ML)-Based Analytical Methods Using Clinical Data from Patients with Spinal Cord Injury |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/06 10:34:37 |
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Basic information
Public title
Development of Artificial Intelligence and Machine Learning (AI/ML)-Based Analytical Methods Using Clinical Data from Patients with Spinal Cord Injury
Acronym
SCI-AIM
Scientific Title
Development of Artificial Intelligence and Machine Learning (AI/ML)-Based Analytical Methods Using Clinical Data from Patients with Spinal Cord Injury
Scientific Title:Acronym
SCI-AIM
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop artificial intelligence and machine learning (AI/ML)-based analytical methods for prognosis prediction and patient stratification using existing clinical data from patients with spinal cord injury, and to evaluate their potential clinical applications.
Basic objectives2
Others
Basic objectives -Others
Development and performance evaluation of artificial intelligence and machine learning (AI/ML)-based analytical methods for prognosis prediction and patient stratification using existing clinical data from patients with spinal cord injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Performance of the artificial intelligence and machine learning (AI/ML)-based analytical methods developed using clinical data from patients with spinal cord injury.
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 registered in the spinal cord injury database at the Spinal Injuries Center between January 1, 2012, and September 30, 2026.
Key exclusion criteria
1. Patients with insufficient clinical information.
3. Patients not registered in the spinal cord injury database of the Spinal Injuries Center.
4. Patients who withdrew consent for participation in this study.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
keio.spinalregen@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Sugai |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
keio.spinalregen@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Spinal Injuries Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Keio University school of medicine
Address
35 Shinanomachi, Shinjuku, Tokkyo
Tel
med-rinri-jimu@adst.keio.ac.jp
med-rinri-jimu@adst.keio.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
| 2026 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Descriptive Study
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071522
