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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044387
Receipt No. 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 2021/06/01

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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
Email 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
Email sugitaka@tottori-u.ac.jp

Sponsor
Institute Tottori University School of Medicine,Department of Gastroenterology and Nephrology
Institute
Department

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
Email 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 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
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
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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