UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Acronym	Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Scientific Title	Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Scientific Title:Acronym	Diagnosing anaemia from digital images of the palpebral conjunctiva by machine learning
Region	Japan

Condition
Condition	anemia
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this cross-sectional study, we aim to assess the reliability of machine learning for digital image of palpable conjunctiva as predictive marker of anemia. The setting is the outpatient department and general internal medicine department of Dokkyo Medical University, a tertiary university hospital, Tochigi, Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary study outcome is a diagnostic accuracies (sensitivity, specificity, positive predictive value, negative predictive value and ROC curve by cross validation etc) of predictive hemoglobin from machine learning for digital image of palpebral conjunctiva. The reference standard is the patient's serum hemoglobin.
Key secondary outcomes	The difference of the primary study outcome and the doctor's predictive value for the patient's serum hemoglobin

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
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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	This study's participants will consist of patients who are performed the laboratory test to Outpatient department and general internal medicine department of Dokkyo Medical University, from May 2020 to April 2021.
Key exclusion criteria	1. Those who cannot get digital image of palpebral conjunctiva. 2. Those who do not consent to participate in this study.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Takanobu Middle name Last name Hirosawa
Organization	Dokkyo Medical University
Division name	Department of Diagnostic and Generalist Medicine
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Email	hirosawa@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Takanobu Middle name Last name Hirosawa
Organization	Dokkyo Medical University
Division name	Department of Diagnostic and Generalist Medicine
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Homepage URL
Email	hirosawa@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University, Department of Diagnostic and Generalist Medicine
Institute
Department

Funding Source
Organization	self funding
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	The Ethics Committee of Dokkyo Medical University
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
Tel	0282-86-1111
Email	r-kenkyu@dokkyomed.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	2020 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	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 02 Day
Date of IRB	2020 Year 05 Month 02 Day
Anticipated trial start date	2020 Year 05 Month 02 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The following information will be gathered from medical chart review - age - gender - chief complain - ethnic - medical history until 2 weeks before (dyspnea, anorexia, body weight loss, fever, cold sweat, melena, blood stool, hematemesis) - past medical history (congestive heart failure, ischemic heart disease, syncope, deep venous thrombosis, pulmonary embolism, pneumonia, gastrointestinal bleeding, cirrhosis and other liver diseases, diarrhea, transients ischemic attack, stroke, seizure, diabetic ketoacidosis, sepsis, HIV, tuberculosis and other infection, hematologic malignancy, thalassemia, kidney disfunction, collagen diseases, annual health check-up, hypertension, hyperlipidemia, diabetes, optic diseases, etc) - blood infusion until 2 weeks before - eye drops - smoking history - vital sign (blood pressure, heart rate, body temperature, respiratory rate, SpO2) - laboratory data (Hb, Hct, RBC, MCV, MCH, MCHC, RDW, reticulocyte, rouleaux formation, WBC, platelet, CRP, ESR, lactate, Cre, BUN, AST, ALT, T-bil, Fe, TIBC, UIBC, ferritin, folate acid, vitamin B12, urinary test) - final diagnosis The following information will be gathered for this study - digital image of palpebral conjunctiva - predictive serum hemoglobin by doctor before laboratory data - doctor's post graduate year

Management information
Registered date	2020 Year 05 Month 22 Day
Last modified on	2020 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046208

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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