UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044387 |
|---|---|
| Receipt number | R000050702 |
| Scientific Title | Construction of quantification method for jaundice/anemia by transconjunctival medical optical imaging |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/06/02 10:30:17 |
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Basic information
Public title
Construction of jaundice/anemia detection method using a smartphone
Acronym
Construction of jaundice/anemia detection method using a smartphone
Scientific Title
Construction of quantification method for jaundice/anemia by transconjunctival medical optical imaging
Scientific Title:Acronym
Construction of quantification method for jaundice/anemia by transconjunctival medical optical imaging
Region
| Japan |
Condition
Condition
Jaundice / anemia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to establish a method for acquiring jaundice/anemia findings by non-contact technology by acquiring digital images of the eyeball and eyelid conjunctiva, quantifying the color tone, and comparing it with blood data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Analyze the correlation between the jaundice ocular conjunctiva acquired by digital images and blood data (bilirubin value).
-Analyze the correlation between the palpebral conjunctiva of anemia acquired by digital images and blood data (hemoglobin value).
-Compare and examine the changes in color tone between the face and the conjunctiva of the eye acquired by digital images.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults (20-79 years old) with jaundice or anemia. The disease group should be adults with jaundice (total bilirubin level of 3 mg/dl or higher) or anemia (hemoglobin level of less than 8 g / dL). The control group shall have no jaundice (total bilirubin value <2 mg/dl) and no anemia (hemoglobin value 12 g / dl or more) by a blood test.
Key exclusion criteria
1) If you have hyperemia or ophthalmic disease in the conjunctiva of the eye
2) Those who the principal investigator deems inappropriate as a patient
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Sugihara |
Organization
Tottori University School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
6838504
Address
36-1 Nishicho, Yonago City, Tottori, JAPAN
TEL
0859-38-6527
sugitaka@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Sugihara |
Organization
Tottori University School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
683-8504
Address
36-1 Nishicho, Yonago City, Tottori, JAPAN
TEL
0859-38-6527
Homepage URL
sugitaka@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University School of Medicine,Department of Gastroenterology and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Tottori University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Section, Corporate Planning Division, Yonago District Office, Tottori University
Address
36-1 Nishicho, Yonago City, Tottori, JAPAN
Tel
0859-38-7014
me-rinshoukenkyu@ml.adm.tottori-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
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/13/10/1767
Number of participants that the trial has enrolled
51
Results
The maximum hue degree (MHD) optimal cutoff to identify jaundice was 40.8 (sensitivity 81% and specificity 80%), and the AUROC was 0.842
Results date posted
| 2023 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special study drug or equipment is used in this study.
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050702
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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