UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053870 |
|---|---|
| Receipt number | R000061460 |
| Scientific Title | Research on screening for various diseases and predicting the risk of disease onset/severity based on blood protein data or walking posture data |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2025/08/01 15:42:11 |
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Basic information
Public title
Research on screening for various diseases and predicting the risk of disease onset/severity based on blood protein data or walking posture data
Acronym
Research on screening for various diseases and predicting the risk of disease onset/severity based on blood protein data or walking posture data
Scientific Title
Research on screening for various diseases and predicting the risk of disease onset/severity based on blood protein data or walking posture data
Scientific Title:Acronym
Research on screening for various diseases and predicting the risk of disease onset/severity based on blood protein data or walking posture data
Region
| Japan |
Condition
Condition
glaucoma, mild cognitive impairment, dementia
Classification by specialty
| Hematology and clinical oncology | Ophthalmology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Blood protein, gait posture, visual field, and cognitive function measurements will be performed on glaucoma, mild cognitive impairment (MCI), and dementia patients and healthy controls to create a classification model and evaluate the accuracy of the classification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC of classification model
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who are able to make their own decision to accept or reject participation in the study
Persons diagnosed with glaucoma, mild cognitive impairment (MCI), or dementia, or healthy individuals
Key exclusion criteria
Exclude those who meet any of the following criteria 1-4
(1)People with systemic lupus erythematosus (SLE)
(2)Pregnant women
(3)Those who are unable to walk independently
(4)Persons who are unable to give their written or electromagnetic consent to participate in the research
Target sample size
390
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7294
n-himori@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Nagai |
Organization
Tohoku University Graduate School of Medicine
Division name
Well-being Design Joint Research Chair
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
090-1451-5689
Homepage URL
katsuyuki.nagai.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2024 | Year | 03 | Month | 15 | 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
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood protein tests, gait posture tests, ophthalmological tests, and psychological tests will be performed on glaucoma, mild cognitive impairment (MCI), and dementia patients and healthy controls to create a classification model and evaluate the accuracy of the classification.
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061460
